PRESCISION SPINAL CORD STIMULATOR SYSTEM (SCS)
FDA premarket approval P030017/S116 · decided 2011-03-28
Approval details
- PMA number
- P030017
- Supplement
- S116
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRESCISION SPINAL CORD STIMULATOR SYSTEM (SCS)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2011-03-01
- Decision date
- 2011-03-28
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- ADDITION OF AN ALTERNATE ASSEMBLY METHOD FOR THE LEADS AND EXTENSIONS FOR THE PRECISION® SPINAL CORD STIMULATOR (SCS) SYSTEM.
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