SPINAL CORD STIMULATION SYSTEMS
FDA premarket approval P840001/S175 · decided 2011-01-20
Approval details
- PMA number
- P840001
- Supplement
- S175
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SPINAL CORD STIMULATION SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2010-12-21
- Decision date
- 2011-01-20
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL TO ADD NEW PRECAUTIONS REQUIRED FOR COMPLIANCE WITH APPLICABLE PORTIONS OF THE ¿IEC 60601-1 STANDARD FOR MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE.¿
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |