|
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 | S048 |
Date Received | 12/20/2006 |
Decision Date | 05/09/2007 |
Withdrawal Date
|
05/07/2018 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ALTERNATE AUTOMATED TEST EQUIPMENT (ATE). |