|
Device | MEDTRONIC MODEL 7223CX MICRO JEWEL II(TM) |
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 | S024 |
Date Received | 04/24/1996 |
Decision Date | 11/08/1996 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MEDTRONIC MODEL 7218 B/C/D/E WITH THE MODEL 9896 SOFTWARE AND THE MEDTRONIC MODEL 7223 CX MICRO JEWELL II WITH MODEL 5705 ACTIVE CAN EMULATOR AND MODEL 9955 SOFTWARE |