PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
FDA premarket approval P030017/S140 · decided 2012-10-01
Approval details
- PMA number
- P030017
- Supplement
- S140
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2012-08-07
- Decision date
- 2012-10-01
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR MINOR PACKAGING DESIGN CHANGES TO THE INNER TRAY AND INNER TRAY COVER FOR THE PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM IMPLANTABLE PULSE GENERATOR (IPG) KITS.
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