• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSEPRAFILM BIORESORBABLE MEMBRANE
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorable, adhesion
Applicant
GENZYME CORP.
55 cambridge parkway
cambridge, MA 02142
PMA NumberP950034
Supplement NumberS011
Date Received02/11/1999
Decision Date03/11/1999
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the extension of the expiration dating of Seprafilm(TM) Bioresorbable Membrane from 30 months to 36 months.
-
-