|
Device | MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P920015 |
Supplement Number | S146 |
Date Received | 12/22/2014 |
Decision Date | 10/19/2015 |
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 |
Review Memo | Review Memo |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE REMOTE CONTROL SOFTWARE ON THE 2090 PROGRAMMER. |
Approval Order | Approval Order |