PMA P880086S062
- Device
- AFFINITY SR/DR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S062
- Product code
- KRG
- Decision date
- 1999-06-21
- Classification
- Programmer, Pacemaker
- Generic name
- Programmer, pacemaker
- Approval order statement
- The 30-Day Notice requested elimination of redundant testing in the Affinity pulse generator manufacturing process.
Current openFDA PMA Record#
- Device
- AFFINITY SR/DR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S062
- Product code
- KRG
- Generic name
- Programmer, pacemaker
- Decision date
- 1999-06-21
- Decision code
- OK30
- Date received
- 1999-05-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-Day Notice requested elimination of redundant testing in the Affinity pulse generator manufacturing process.