PMA P030017S240
- Device
- PRECISION SPECTRA AND PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S240
- Product code
- LGW
- Decision date
- 2015-11-24
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- USE OF AN UPDATED TEST EQUIPMENT SYSTEM USED FOR TESTING THE PRECISION SPECTRA REMOTE CONTROL USED TO SUPPORT THE PRECISION SPECTRA IPG AND THE FREELINK REMOTE CONTROL USED TO SUPPORT BOTH PRECISION SPECTRA AND PRECISION NOVI IPGS.
Current openFDA PMA Record#
- Device
- PRECISION SPECTRA AND PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S240
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2015-11-24
- Decision code
- OK30
- Date received
- 2015-10-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF AN UPDATED TEST EQUIPMENT SYSTEM USED FOR TESTING THE PRECISION SPECTRA REMOTE CONTROL USED TO SUPPORT THE PRECISION SPECTRA IPG AND THE FREELINK REMOTE CONTROL USED TO SUPPORT BOTH PRECISION SPECTRA AND PRECISION NOVI IPGS.