PMA P010032S144
- Device
- Proclaim IPG
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S144
- Product code
- LGW
- Decision date
- 2018-11-14
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Extending the primer solution mix time for header attach for Proclaim and Infinity IPGs.
Current openFDA PMA Record#
- Device
- Proclaim IPG
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S144
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2018-11-14
- Decision code
- OK30
- Date received
- 2018-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Extending the primer solution mix time for header attach for Proclaim and Infinity IPGs.