|
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 | S012 |
Date Received | 06/11/2009 |
Decision Date | 07/27/2009 |
Product Code |
MLV |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A DUPLICATE MANUFACTURING SITE FOR THE FINAL ASSEMBLY STEP OF THE DEVICE. |