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Device | CARDIOSEAL SEPTAL OCCULUSION SYSTEM WITH QWIK LOAD |
Generic Name | Transcatheter septal occluder |
Applicant | NMT MEDICAL, INC. 27 WORMWOOD ST. BOSTON, MA 02210 |
PMA Number | P000049 |
Supplement Number | S011 |
Date Received | 03/02/2004 |
Decision Date | 03/24/2004 |
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 IN THE MANUFACTURING PROCESS OF THE CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD WHICH INVOLVES A CHANGE TO THE BIOBURDEN SAMPLING PLAN TO ELIMINATE REDUNDANT QUARTERLY TESTING. |