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. |
|
Device | GORE HELEX SEPTAL OCCLUDER |
Generic Name | Transcatheter septal occluder |
Applicant | W.L. GORE & ASSOCIATES,INC 32360 N NORTH VALLEY PARKWAY PHOENIX, AZ 85085-1505 |
PMA Number | P050006 |
Supplement Number | S039 |
Date Received | 06/04/2014 |
Decision Date | 07/02/2014 |
Product Code |
MLV |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY, BACTERIALENDOTOXIN TESTING, HEAVY METALS AS LEAD (HMAL) AND NON-VOLATILE RESIDUE (NVR) TESTING IN THE EAST COAST TESTING CENTER. |
Post-Approval Study | Show Report Schedule and Study Progress |
|
|