PMA P010032S089
- Device
- TRIPOLE 16/16C,EXCLAIM,LAMITRODE 4/44/44C/88/S-4/S8, PENTA,OCTRODE, AND QUATTRODE LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S089
- Product code
- LGW
- Decision date
- 2014-12-18
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- IMPLEMENT MANUFACTURING PROCESS CHANGES.
Current openFDA PMA Record#
- Device
- TRIPOLE 16/16C,EXCLAIM,LAMITRODE 4/44/44C/88/S-4/S8, PENTA,OCTRODE, AND QUATTRODE LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S089
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2014-12-18
- Decision code
- OK30
- Date received
- 2014-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENT MANUFACTURING PROCESS CHANGES.