PMA P880086S143
- Device
- AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S143
- Product code
- NVZ
- Decision date
- 2007-05-07
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.
Current openFDA PMA Record#
- Device
- AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S143
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2007-05-07
- Decision code
- APPR
- Date received
- 2007-04-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.