PMA P880086S211
- Device
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S211
- Product code
- NVZ
- Decision date
- 2012-05-07
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR LEAD FAILURE DETECTION AND TELEMETRY ENHANCEMENTS.
Current openFDA PMA Record#
- Device
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S211
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2012-05-07
- Decision code
- APPR
- Date received
- 2011-11-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR LEAD FAILURE DETECTION AND TELEMETRY ENHANCEMENTS.