PMA P880086S217
- Device
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S217
- Product code
- NVZ
- Decision date
- 2012-03-21
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR THE MODEL 3330 VERSION 13.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM TO BE USED WITH THE AFFINITY/ INTEGRITY/VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS.
Current openFDA PMA Record#
- Device
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S217
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2012-03-21
- Decision code
- APPR
- Date received
- 2012-02-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 3330 VERSION 13.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM TO BE USED WITH THE AFFINITY/ INTEGRITY/VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS.