|
Device | CARDIOSEAL SEPTAL OCCLUSION SYSTEM W/QWIKLOAD |
Generic Name | Transcatheter septal occluder |
Applicant | NMT MEDICAL, INC. 27 WORMWOOD ST. BOSTON, MA 02210 |
PMA Number | P000049 |
Supplement Number | S004 |
Date Received | 05/20/2002 |
Decision Date | 06/19/2002 |
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 CHANGE TO THE INCOMING INSPECTION FOR TYVEK/MYLAR POUCHES USED FOR PACKAGING THE IMPLANT AND DELIVERY SYSTEM. |
Post-Approval Study | Show Report Schedule and Study Progress |