RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS
FDA premarket approval P840001/S307 · decided 2015-07-16
Approval details
- PMA number
- P840001
- Supplement
- S307
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2015-06-17
- Decision date
- 2015-07-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- MANUFACTURING CHANGE TO EXPAND THE UPPER LIMIT OF THE TEMPERATURE RANGE FOR THE CONDITIONING PHASE OF THE STANDARD STERILIZATION CYCLE AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE AND RICE CREEK MANUFACTURING FACILITIES.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |