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 | INVIVE, INTUA, VISIONIST, VALITUDE CRT-P RESYNCHRONIZATION DEVICES |
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 | S131 |
Date Received | 12/21/2015 |
Decision Date | 02/05/2016 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | real-time process |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for software changes to the patient management system. |
|
|