Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MODEL 7220 B/C/D/E JEWEL(R) PLUS, 7202 D/E, 7219 BDE, 7221 B/C/CXDE |
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 | S027 |
Date Received | 07/15/1996 |
Decision Date | 10/22/1996 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXTENDING THE SHELF LIFE TO 18 MONTHS FOR THE MODELS 7219 B/D/E, 7202 D/E JEWEL, 7220 B/C/D/E/ JEWEL PLUS AND 7221 B/C/CX/D/E/ MICROJEWEL(TM) |
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