PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
FDA premarket approval P030017/S106 · decided 2010-06-23
Approval details
- PMA number
- P030017
- Supplement
- S106
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2010-05-25
- Decision date
- 2010-06-23
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- CHANGE IN THE ASSEMBLY OF THE CHARGER 2.0 PRINTED CIRCUIT BOARD (PCB) AT THE CURRENT SUPPLIER.
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