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U.S. Department of Health and Human Services

Import Alert 74-03
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 74-03
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Polyvinyl Alcohol Foam Particles (PVA Foam)"

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.

Guidance:
Districts may detain, without physcical examination, all shipments of Polyvinyl Alcohol Foam from the known shipper and from all other sources identifed in the attachmnet to this alert.

Product Description:
Polyvinyl Alcohol Foam Particles (PVA Foam).

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)]."

OASIS charge code - NO PMA

List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)


FRANCE
Laboratoire Nycomed Ingenor Sa
Date Published : 09/16/2009

25, Quai De La Gare - C.E. No. 19 , Paris Cedex, FRANCE
74 - - - -- Cardiovascular
Date Published: 09/16/2009

Notes:Polyvinyl Alcohol Foam Particles

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