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.
 
DeviceGORE CARDIOFORM Septal Occluder
Generic NameTranscatheter septal occluder
ApplicantW.L. GORE & ASSOCIATES,INC
32360 N NORTH VALLEY PARKWAY
PHOENIX, AZ 85085-1505
PMA NumberP050006
Supplement NumberS094
Date Received07/16/2021
Decision Date08/13/2021
Product Code MLV 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Modify the vertical and post-bake ovens used to manufacture delivery sheaths.
-
-