|
Device | GORE HELEX SEPTAL OCCLUDER, GORE CARDIOFORM 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 | S047 |
Date Received | 05/14/2015 |
Decision Date | 06/11/2015 |
Product Code |
MLV |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENT A CHANGE IN THE TEST METHOD USED FOR RECEIVING ACCEPTANCE ACTIVITIES FOR RAW MATERIALS. |