PMA P880086S257
- Device
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S257
- Product code
- NVZ
- Decision date
- 2015-07-13
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR THE MERLIN@HOME EX1150W/EX1100W-MX (MODEM EXTRACTED) TO BE USED WITH THE DEVICES.
Current openFDA PMA Record#
- Device
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S257
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2015-07-13
- Decision code
- APPR
- Date received
- 2015-05-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MERLIN@HOME EX1150W/EX1100W-MX (MODEM EXTRACTED) TO BE USED WITH THE DEVICES.