|
Device | TRANSVENE EPICARDIAL LEAD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P900061 |
Supplement Number | S101 |
Date Received | 04/12/2011 |
Decision Date | 05/12/2011 |
Product Code |
LWS |
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 CHANGES TO THE NELIPAK SEALER MANUFACTURING PROCESS; INCLUDING A PROCESS RECIPE CHANGE, NEW TRAY CONFIGURATIONS, AND THE ADDITION OF A MONITORING TEST. |