PMA P030017S179
- Device
- PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S179
- Product code
- LGW
- Decision date
- 2013-09-26
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- CHANGE THE SOLDER FILLET HEIGHT REQUIREMENT FOR THE PRINTED CIRCUIT BOARD ASSEMBLY.
Current openFDA PMA Record#
- Device
- PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S179
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2013-09-26
- Decision code
- OK30
- Date received
- 2013-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE THE SOLDER FILLET HEIGHT REQUIREMENT FOR THE PRINTED CIRCUIT BOARD ASSEMBLY.