IA#74-02 --- 4/26/90
TYPE OF ALERT: Automatic Detention
PRODUCT : Symbion's Jarvik Total Artificial Heart and Symbion's Acute
Ventricular Assist Device
PRODUCT 74DSO (Artificial Heart)
CODES(S) : 74DSQ (Ventricular Assist Device)
PROBLEM : Due to safety consideration and noncompliance with the
Investigational Device Exemption (IDE) Regulations (21 CFR
Part 812) CDRH withdrew approval for the IDE's permitting
clinical research of the two medical devices.
PAC : 82008
COUNTRY : Known countries: Canada and West Germany
MANUFACTURER/
SHIPPER : Symbion, Inc.
Vancouver, B.C., Canada
-or-
Symbion, Inc.
West Germany
CHARGE : "The article is subject to refusal of admission pursuant to
Section 801(a)(3) of the Act in that it appears to be a Class
III device, for which no approval under Section 515 is in
effect and no exemption for investigational use is in effect.
[Adulteration Section 501(f)(1)(B).]"
RECOMMENDING
OFFICE : CDRH, Office of Compliance and Surveillance, Division of
Compliance Operations, Regulatory Guidance Branch, HFZ-323.
REASON FOR
ALERT : To prevent importation of medical devices for commercial
distribution or investigational use that do not have premarket
approval, and for which no exemption for investigational use
is in effect.
INSTRUCTIONS : Automatically detain Symbion's Jarvik Total Artificial Heart
and Symbion's Acute Ventricular Assist Device from any foreign
source unless all of the following conditions are met:
1 The devices are used, and clearly labeled, for testing
(research) purposes only.
2 The devices are not intended for commercial distribution
or investigational use.
3 The devices are consigned to Symbion, Inc. Locations are
as follows:
Symbion, Inc. Symbion, Inc.
825 North 300 West 7855 South Parkway, Suite
211
Salt Lake City, Utah 84103 Tempe, Arizona 85284
FOI : No purging is required.
KEYWORDS : Symbion, Jarvik, Artificial Heart, Ventricular, Device.
|
