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 | SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | St. Jude Medical, Inc. 15900 VALLEY VIEW Court SYLMAR, CA 91342 |
PMA Number | P880006 |
Supplement Number | S071 |
Date Received | 05/02/2011 |
Decision Date | 08/03/2011 |
Withdrawal Date
|
05/07/2018 |
Product Code |
NVZ |
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 MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE. |
Approval Order | Approval Order |
|
|