PMA P010032S077
- Device
- TRIPOLE 16 AND TRIPOLE 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44, LAMITRODE 44C LEADS, LAMITRODE 88 LEAD
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S077
- Product code
- LGW
- Decision date
- 2014-04-04
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- ADD A MANUFACTURING SPECIFICATION FOR MINIMUM ELECTRODE WINDOW CUT OUT DIMENSIONS.
Current openFDA PMA Record#
- Device
- TRIPOLE 16 AND TRIPOLE 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44, LAMITRODE 44C LEADS, LAMITRODE 88 LEAD
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S077
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2014-04-04
- Decision code
- OK30
- Date received
- 2014-03-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A MANUFACTURING SPECIFICATION FOR MINIMUM ELECTRODE WINDOW CUT OUT DIMENSIONS.