Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | INSYNC; INSYNC III; ATTAIN LEAD; ATTAIN OTW LEAD |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S217 |
Date Received | 09/06/2013 |
Decision Date | 02/27/2014 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING UPDATE TO INCLUDE THE RESULTS FROM THE POST-APPROVAL STUDY, SPECIFICALLY THE MEDTRONIC INSYNC REGISTRY POST APPROVAL STUDY |
|
|