|
Device | MODTRONIC(R) MODELS 7219/B/C/D/E AND 7202C/D/E |
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 | S021 |
Date Received | 11/02/1995 |
Decision Date | 02/04/1997 |
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 ALTERNATE FIRMWARE/HARDWARE DESIGN FOR THE MEDTRONIC (R) MODELS 7219B/C/D/E AND 7202C/D/E |