|
Device | JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM |
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 | S011 |
Date Received | 05/30/1995 |
Decision Date | 08/01/1995 |
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 TECOTHANE 75D POLYURETHANE RESIN IN MEDTRONIC IMMPLANTABLE CARDIOVERTER DEFIBRILLATORS. |