PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM
FDA premarket approval P030017/S019 · decided 2007-03-02
Approval details
- PMA number
- P030017
- Supplement
- S019
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2007-02-15
- Decision date
- 2007-03-02
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR UPDATES TO THE ?PHYSICIAN LEAD MANUAL? (FOR LINEAR LEADS AND EXTENSIONS) LABELING TO HELP MINIMIZE THE OCCURRENCE OF STYLET PENETRATION.
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