PMA P030017S171
- Device
- PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S171
- Product code
- LGW
- Decision date
- 2013-07-19
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- EXPAND THE DURATION OF THE LEAD REFLOW MANUFACTURING STEP.
Current openFDA PMA Record#
- Device
- PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S171
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2013-07-19
- Decision code
- OK30
- Date received
- 2013-06-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EXPAND THE DURATION OF THE LEAD REFLOW MANUFACTURING STEP.