|
Device | CARDIOSEAL SEPTAL OCCLUSION WITH QWIK LOAD |
Generic Name | Transcatheter septal occluder |
Applicant | NMT MEDICAL, INC. 27 WORMWOOD ST. BOSTON, MA 02210 |
PMA Number | P000049 |
Supplement Number | S019 |
Date Received | 08/08/2007 |
Decision Date | 01/17/2008 |
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 TO REMOVE THE MULLINS BURST TEST REQUIREMENT FOR THE DEVICE. |
Post-Approval Study | Show Report Schedule and Study Progress |