PMA P030017S356
- Device
- Precision Spinal Cord Stimulator (SCS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S356
- Product code
- LGW
- Decision date
- 2023-01-06
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Introduce an additional cleanroom facility at your Clonmel Ireland manufacturing facility.
Current openFDA PMA Record#
- Device
- Precision Spinal Cord Stimulator (SCS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S356
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2023-01-06
- Decision code
- OK30
- Date received
- 2022-12-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce an additional cleanroom facility at your Clonmel Ireland manufacturing facility.