PMA P880086S238
- Device
- IDENTITY,SUSTAINXL,VERITY,VICTORY,ZEPHYR,ACCENT FAMILIES OF PACEMAKER DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S238
- Product code
- NVZ
- Decision date
- 2014-03-31
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR A MODIFICATION IN THE SEPARATOR COMPONENT UTILIZED IN THE BATTERIES OF THE IMPLANTABLE PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- IDENTITY,SUSTAINXL,VERITY,VICTORY,ZEPHYR,ACCENT FAMILIES OF PACEMAKER DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S238
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2014-03-31
- Decision code
- APPR
- Date received
- 2014-01-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION IN THE SEPARATOR COMPONENT UTILIZED IN THE BATTERIES OF THE IMPLANTABLE PULSE GENERATORS.