Dockets Entered on November 28, 2005

Dockets Management



Dockets Entered On November 28, 2005 Table of Contents



Docket #	Title

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

2005M-0473	P040003 - ExAblate 2000 System, Approved 10/22/04

2005M-0474	P040013 - GEM 21S (Growth-factor Enhanced Matrix), Approved 11/18/05

2005M-0475	P020045 - 7F Freezor Cardiac CryoAblation Catheter and CCT.2 CryoConsole System, Approved 4/17/03

2005M-0476	P040042 - Therapy Dual 8 Cardiac Ablation System, Approved 11/18/05

2005M-0477	P040047 -Coaptite, Approved 11/10/05

2005M-0478	P030056 - ADVIA Centaur HCV ReadyPack Reagents and ADVIA Centaur HCV Quality Control Materials, Approved December 22, 2004

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

LET 16934	Nature's Way	Vol #:	153

LET 16935	Highland Laboratories	Vol #:	153

LET 16936	Pharmaville LLC	Vol #:	153

LET 16937	Michael's Naturopathic Programs	Vol #:	153

LET 16938	Pharmavite LLC	Vol #:	153

LET 16939	Pharmavite LLC	Vol #:	153

LET 16940	Pharmavite LLC	Vol #:	153

LET 16941	RKS Inc.	Vol #:	153

LET 16942	Novogen, Inc.	Vol #:	153

LET 16943	Daiwa Health Development Inc.	Vol #:	153

LET 16944	CocoaLife, LP	Vol #:	153

LET 16945	Perrigo Company of South Carolina	Vol #:	153

LET 16946	Perrigo Company of South Carolina	Vol #:	153

LET 16947	Perrigo Company of South Carolina	Vol #:	153

LET 16948	Perrigo Company of South Carolina	Vol #:	153

LET 16949	Perrigo Company of South Carolina	Vol #:	153

LET 16950	Natural Organics, Inc.	Vol #:	153

LET 16951	Natural Organics Inc.	Vol #:	153

LET 16952	Hillestad Pharmaceuticals	Vol #:	153

LET 16953	Hillestad Pharmaceuticals	Vol #:	153

LET 16954	NDS Nutrition, LLC	Vol #:	153

LET 16955	New Health Systems,d.b.a. Chicken Soup	Vol #:	153

LET 16956	New Health Systems,d.b.a. Chicken Soup	Vol #:	153

LET 16957	New Health Systems, d.b.a. Chicken Soup	Vol #:	153

LET 16958	New Health systems, d.b.a. Chicken Soup	Vol #:	153



LET 16959	New Health Systems, d.b.a. Chicken Soup	Vol #:	153

LET 16960	NDS Nutrition, LLC	Vol #:	153

LET 16961	NDS Nutrition, LLC	Vol #:	153

LET 16962	NDS Nutrition,LLC	Vol #:	153

LET 16963	NDS Nutirtion, LLC	Vol #:	153

LET 16964	NDS Nutritiion, LLC	Vol #:	153

LET 16965	NDS Nutrition, LLC	Vol #:	153

LET 16966	NDS Nutrition, LLC	Vol #:	153

LET 16967	NDA Nutrition, LLC	Vol #:	153

LET 16968	NDS Nutrition, LLC	Vol #:	153

LET 16969	NDS Nutrition, LLC	Vol #:	153

LET 16970	NDS Nutrition, LLC	Vol #:	153

LET 16971	NDS Nutrition, LLC	Vol #:	153

LET 16972	NDS Nutrition, LLC	Vol #:	153

LET 16973	NDS Nutrition, LLC	Vol #:	153

LET 16974	NDA Nutrition, LLC	Vol #:	153

LET 16975	NDS Nutrition, LLC	Vol #:	153

LET 16976	NDS Nutrition, LLC	Vol #:	153

2001P-0230	Domestic Marketing & Importation of Transgenic Fish

C 1364	J. Frazier	Vol #:	259

2002N-0273	Animal Proteins Prohibited in Ruminant Feed

C 129	J. Zimmerman	Vol #:	21

C 130	M. Lingenfelter	Vol #:	21

C 131	E. Rissler	Vol #:	21

C 132	A. Stolzfus	Vol #:	21

C 133	C. and I Close	Vol #:	21

C 134	J. Sidebottom	Vol #:	21

C 135	T. Paugh	Vol #:	21

C 136	L. Duram	Vol #:	21

C 137	C. Shimkus	Vol #:	21

C 138	Reddemeade Farm, Inc.	Vol #:	21

C 139	J. Purillo	Vol #:	21

C 140	P. Torre	Vol #:	21

C 141	A. Marquez	Vol #:	21

C 142	N. Camargo	Vol #:	21



C 143	M. Cole	Vol #:	21

C 144	J. Vaue	Vol #:	21

C 145	Eligible	Vol #:	21

C 146	Eligible	Vol #:	21

C 147	D. Sanchez	Vol #:	21

C 148	A. Rodarte	Vol #:	21

C 149	E. Anguiano	Vol #:	21

C 150	Eligible	Vol #:	21

C 151	J. Cruz	Vol #:	21

C 152	B. Sanchez	Vol #:	21

C 153	Eligible	Vol #:	21

C 154	Eligible	Vol #:	21

C 155	E. Rabang	Vol #:	21

C 156	Eligible	Vol #:	21

C 157	Eligible	Vol #:	21

C 158	G. Zuniga	Vol #:	21

C 159	F. Juares	Vol #:	21

C 160	G. Castilto B.	Vol #:	21

C 161	L. Delgadillo	Vol #:	21

C 162	Eligible	Vol #:	21

C 163	F. Provencal	Vol #:	21

C 164	R. Banuelos	Vol #:	21

C 165	Eligible	Vol #:	21

C 166	W. Rolow	Vol #:	23

C 167	Eligible	Vol #:	23

C 168	Eligible	Vol #:	23

C 169	Eligible	Vol #:	23

C 170	R. Hogan	Vol #:	23

C 171	Eligible	Vol #:	23

C 172	F. Beltrain	Vol #:	23

C 173	J. Gaua M.	Vol #:	23

C 174	G. Book	Vol #:	23

C 175	V. Enriquez	Vol #:	23

C 176	S. Ramor	Vol #:	23

C 177	Eligible	Vol #:	23

C 178	Eligible	Vol #:	23

C 179	J, Luna	Vol #:	23



C 180	L. Vasquez	Vol #:	23

C 181	J. England	Vol #:	23

C 182	S. Mobeoly	Vol #:	23

C 183	B. Gutierrez, Jr.	Vol #:	23

C 184	Eligible	Vol #:	23

C 185	N. Pavva	Vol #:	23

C 186	D. Huertas	Vol #:	23

C 187	A. Lopez	Vol #:	23

C 188	Eligible	Vol #:	23

C 189	H. Plascencia	Vol #:	23

C 190	Eligible	Vol #:	23

C 191	Eligible	Vol #:	23

C 192	J. Servin	Vol #:	23

C 193	L. Salinas	Vol #:	23

C 194	J. Pinedo	Vol #:	23

C 195	E. Pena	Vol #:	23

C 196	V. Mendoza	Vol #:	23

C 197	P. Garcia	Vol #:	23

C 198	M. Guzman	Vol #:	23

C 199	W. Joe	Vol #:	23

C 200	P. Sauers	Vol #:	23

C 201	L. Molesworth, VMD	Vol #:	24

C 202	A. Tontowi	Vol #:	24

C 203	J. Fuentes	Vol #:	24

C 204	H. Sanabria	Vol #:	24

C 205	C. Gutierrez, Jr.	Vol #:	24

C 206	Eligible	Vol #:	24

C 207	P. Cardenas	Vol #:	24

C 208	K. White	Vol #:	24

C 209	F. Gutierrez	Vol #:	24

C 210	J. Ortiz	Vol #:	24

C 211	J. Gallaga	Vol #:	24

C 212	P. Gutierrez	Vol #:	24

C 213	A. Padilla	Vol #:	24

C 214	A. Lopez	Vol #:	24

C 215	C. Toley	Vol #:	24

C 216	A. Cortes	Vol #:	24



C 217	F. Cardonr	Vol #:	24

C 218	Eligible	Vol #:	24

C 219	Eligible	Vol #:	24

2005M-0473	P040003 - ExAblate 2000 System, Approved 10/22/04

AAV 1	InSightec - North America	Vol #:	1

2005M-0474	P040013 - GEM 21S (Growth-factor Enhanced Matrix), Approved 11/18/05

AAV 1	Biomimetic Pharmaceuticals, Inc.	Vol #:	1

2005M-0475	P020045 - 7F Freezor Cardiac CryoAblation Catheter and CCT.2 CryoConsole System, Approved 4/17/03

AAV 1	Applied Physics	Vol #:	1

2005M-0476	P040042 - Therapy Dual 8 Cardiac Ablation System, Approved 11/18/05

AAV 1	Irvine Biomedical, Inc.	Vol #:	1

2005M-0477	P040047 -Coaptite, Approved 11/10/05

AAV 1	Bioform Medical, Inc.	Vol #:	1

2005M-0478	P030056 - ADVIA Centaur HCV ReadyPack Reagents and ADVIA Centaur HCV Quality Control Materials, Approved December 22, 2004

AAV 1	Bayer Healthcare, LLC	Vol #:	1

Page created on December 7, 2005 RSC

FDA/Dockets Management