PRECIOUS SPINAL CORD STIMULATION (SCS) SYSTEM
FDA premarket approval P030017/S139 · decided 2012-08-15
Approval details
- PMA number
- P030017
- Supplement
- S139
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRECIOUS SPINAL CORD STIMULATION (SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2012-07-16
- Decision date
- 2012-08-15
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- ALLOW CABLE ABLATION TO BE PROCESSED IN-HOUSE.
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