PMA P880086S166
- Device
- AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S166
- Product code
- NVZ
- Decision date
- 2008-09-09
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR THE MODEL 3330 VERSION 6.9.1 SOFTWARE FOR USE ON 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
- S166
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2008-09-09
- Decision code
- APPR
- Date received
- 2008-07-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 3330 VERSION 6.9.1 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.