PMA P030017S233
- Device
- PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S233
- Product code
- LGW
- Decision date
- 2015-09-10
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- ACCEPTANCE OF ALTERNATE LASER MARKING EQUIPMENT USED IN THE CASE HALF ETCHING PROCESS DURING THE MANUFACTURING OF THE PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR (IPG).
Current openFDA PMA Record#
- Device
- PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S233
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2015-09-10
- Decision code
- OK30
- Date received
- 2015-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ACCEPTANCE OF ALTERNATE LASER MARKING EQUIPMENT USED IN THE CASE HALF ETCHING PROCESS DURING THE MANUFACTURING OF THE PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR (IPG).