PMA P880086S066
- Device
- AFFINITY/ENTITY DR,DC,SR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S066
- Product code
- DXY
- Decision date
- 1999-07-27
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for minor modifications to the firmware of the Affinity series of pulse generators.
Current openFDA PMA Record#
- Device
- AFFINITY/ENTITY DR,DC,SR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S066
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 1999-07-27
- Decision code
- APPR
- Date received
- 1999-07-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor modifications to the firmware of the Affinity series of pulse generators.