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 ADHESION BARRIER
Generic NameBarrier, absorbable, adhesion
ApplicantBaxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015
PMA NumberP950034
Supplement NumberS047
Date Received12/23/2016
Decision Date06/29/2017
Product Code MCN 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for revision of product labeling to update information that is to be provided to patients and physicians about the risks associated with use of Seprafilm®. The revisions include contraindication statements regarding use of Seprafilm® in patients with a history of hypersensitivity to Seprafilm® and against use of Seprafilm® being wrapped directly around a fresh anastomotic suture or staple line. Additional product labeling includes new warnings regarding the use of Seprafilm® in patients with infections in the abdominopelvic cavity, patients with abdominopelvic malignancies, the placement of Seprafilm® in locations other than directly associated with the surgical incision lines, use in patients with ongoing local and/or systemic inflammatory cell responses, Seprafilm® use in the presence of other implants, and use in patients requiring re-operation within a 4 week, post-operative period. Furthermore, the change of a current precaution to a warning regarding potential foreign body reactions to Seprafilm® was identified. Finally, the current precaution noting that safety and effectiveness information for use of Seprafilm® in pregnant women has been revised to specifically include pregnant patients undergoing Cesarean section surgical procedures.
-
-