|
Device | MEDTRONIC GEM III AT MODEL 7276 (ICD) |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980050 |
Supplement Number | S002 |
Date Received | 11/06/2000 |
Decision Date | 02/13/2001 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MEDTRONIC GEM III AT MODEL 7276 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WITH THE MODEL 9465 PATIENT ASSISTANT. |
Post-Approval Study | Show Report Schedule and Study Progress |