IA#74-03 --- 8/1/90
TYPE OF ALERT: AUTOMATIC DETENTION
PRODUCT : Polyvinyl Alcohol Foam Particles (PVA Foam)
PRODUCT CODE : 74[][][][][]
HARMONIZED
CODE : 9018
PROBLEM : The product is a Class III medical device requiring
premarket approval (PMA)
PAC : 82008
COUNTRY : France (FR, 350)
MANUFACTURER/
SHIPPER : Ingenor Laboratories, S. A. (aka Ingenor Medical)
Paris, France
MANUFACTURER/
SHIPPERS ID : Unknown
IMPORTER'S ID: Unknown
CHARGE : The article is subject to refusal of admission pursuant
to Section 801(a)(3) in that the article appears to be an
adulterated device within the meaning of Section 501(f)(1)
since it is a class III device for which no premarket approval
(PMA) application has been approved as required by Section
515(a)(2) and no exemption for investigational use
is in effect [Adulteration, 501(f)(1)(B)].
RECOMMENDING
OFFICE : CDRH/OCS/Division of Compliance Operations
Regulatory Guidance Branch, HFZ-323
REASON FOR
ALERT : The product is a Class III medical device requiring premarket
approval. No exemption for investigational use is in effect.
The particles are injected into blood vessels to aid in
the treatment of tumors by blocking the blood supply to
the area of the tumor. However, if the incorrect vessel is
blocked, heart attack or stroke may result.
The device is not approved for commercial distribution or
investigational use.
INSTRUCTIONS : Automatically detain all shipments of Polyvinyl Alcohol
Foam from the above known shipper and from all other sources.
FOI : No purging is required.
KEYWORDS : Polyvinyl, Alcohol, Particles, PVA, Foam, Blood, Vessels,
France
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