PMA P880086S195
- Device
- AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S195
- Product code
- NVZ
- Decision date
- 2011-04-04
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR MODEL 3330 VERSION 12.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
Current openFDA PMA Record#
- Device
- AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S195
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2011-04-04
- Decision code
- APPR
- Date received
- 2010-11-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODEL 3330 VERSION 12.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.