PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM
FDA premarket approval P030017/S247 · decided 2016-03-18
Approval details
- PMA number
- P030017
- Supplement
- S247
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2016-02-19
- Decision date
- 2016-03-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Acceptance of an alternate qualified manufacturing site at the BSN Valencia facility for the laser ablation of the multi-lumen tubes, which are used in the assembly of the Infinion and Infinion CX 16 Contact Leads of the Precision, Precision Spectra, and Precision Novi Spinal Cord Stimulation (SCS) Systems
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