|
Device | MODEL 9881E SOFTWARE (9881E 217214 REVISION:C) |
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 | S019 |
Date Received | 08/14/1995 |
Decision Date | 11/06/1995 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODEL 9881E SOFTWARE, 9881E 217214 REVISION:C, FOR MODEL 9790 AND 9790C PROGRAMMERS WITH MODEL 7216/7217 PCD AND 7201 CD DEVICES |