PMA P030017S198
- Device
- PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S198
- Product code
- LGW
- Decision date
- 2014-08-06
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO THE APPLICATION SPECIFIC INTEGRATED CIRCUIT (ASIC) ON THE BALL GRID ARRAY (BGA) COMPONENT.
Current openFDA PMA Record#
- Device
- PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S198
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2014-08-06
- Decision code
- APPR
- Date received
- 2014-05-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO THE APPLICATION SPECIFIC INTEGRATED CIRCUIT (ASIC) ON THE BALL GRID ARRAY (BGA) COMPONENT.