PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
FDA premarket approval P030017/S080 · decided 2008-10-03
Approval details
- PMA number
- P030017
- Supplement
- S080
- 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
- 2008-09-05
- Decision date
- 2008-10-03
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- MODIFICATION TO THE IMPLANTABLE PULSE GENERATOR (IPG) VIBRATION TEST PROCESS.
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