|
Device | INSYNC CRT-P/INSYNC III 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 | S107 |
Date Received | 01/04/2011 |
Decision Date | 05/13/2011 |
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 |
Approval Order Statement APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER. |
Approval Order | Approval Order |