RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY & VECTRIS SPINAL CORD STIMULATION
FDA premarket approval P840001/S316 · decided 2015-11-20
Approval details
- PMA number
- P840001
- Supplement
- S316
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY & VECTRIS SPINAL CORD STIMULATION
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2015-10-29
- Decision date
- 2015-11-20
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- DECREASING THE FREQUENCY OF DESTRUCTIVE ANALYSIS (DA) SAMPLING OF MEDIUM RATE BATTERIES FROM ONCE EVERY 360/180 PARTS (APPROXIMATELY ONCE PER SHIFT) TO EVERY 50 HOURS OR 2400 PARTS RAN, AND THE ADDITION OF FACTORYWORKS MONITORS FOR POWER AND SPOT CHECKS OF THE LASER WELDS AT MEDTRONIC ENERGY AND COMPONENT CENTER (BROOKLYN CENTER, MN).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |