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 | VISIONIST, VISIONIST X4, VALITUDE, VALITUDE X4, INVIVE, INTUA |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | GUIDANT CORP. 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P030005 |
Supplement Number | S138 |
Date Received | 07/05/2016 |
Decision Date | 12/16/2016 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00606710
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for new CRT-P models with additional software features. |
|
|