PMA P880086S198
- Device
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILIES OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S198
- Product code
- NVZ
- Decision date
- 2011-08-02
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR ADDITIONAL MANUFACTURING SCREENING TESTS FOR A DEVICE COMPONENT.
Current openFDA PMA Record#
- Device
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILIES OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S198
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2011-08-02
- Decision code
- APPR
- Date received
- 2011-03-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ADDITIONAL MANUFACTURING SCREENING TESTS FOR A DEVICE COMPONENT.