|
Device | CONSULTA CRT-P, SYNCRA CRT-P |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S157 |
Date Received | 03/07/2012 |
Decision Date | 06/04/2012 |
Product Code |
OJX |
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 CONSULTA CRT-P MODEL C4TR01 AND SYNCRA CRT-P MODEL C2TR01. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |