PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
FDA premarket approval P030017/S134 · decided 2012-12-21
Approval details
- PMA number
- P030017
- Supplement
- S134
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2012-05-07
- Decision date
- 2012-12-21
- Days to decision
- 228 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE PRECISION SPECTRA SYSTEM WHICH INCLUDES THE FOLLOWING COMPONENTS:1) MODEL SC-1132 PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR (LPG); 2)MODEL SC-440 I PRECISION SPECTRA LPG PORT PLUG; 3) MODEL SC-5132 PRECISION SPECTRA EXTERNAL TRIAL STIMULATOR; 4) MODEL SC-6360-32 PRECISION SPECTRA PATIENT TRIAL BELT; 4) MODEL SC-6500-32 PATIENT TRIAL KIT; 5) MODEL SC-5232 PRECISION SPECTRA REMOTE CONTROL; 6) MODEL SC-5532-1 PRECISION SPECTRA REMOTE CONTROL KIT; 7) MODEL NM-631 0 AND NM-621 0
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