Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
Generic NameBarrier, absorbable, adhesion
ApplicantBaxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015
PMA NumberP950034
Supplement NumberS005
Date Received04/16/1997
Decision Date02/25/1998
Product Code MCN 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
In this supplment the applicant agrees to submit an Investigational Device Exemptions (IDE) application for the modified postapproval safety study, is approved. We believe that this study, with the modifications as discussed, will satisfy the condition ofapproval for this PMA, but we may have additional comments on the IDE botha s it related to the objectives of the postapproval study, depending on your responses, and your objective of collecting outcomes data on the incidence of small bowel obstruction.
-
-