RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME,SPECIFY, & VECTRIS CORD STIMULATION LEADS
FDA premarket approval P840001/S318 · decided 2015-12-23
Approval details
- PMA number
- P840001
- Supplement
- S318
- 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 CORD STIMULATION LEADS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2015-11-23
- Decision date
- 2015-12-23
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- UPDATE OF THE PULL TEST SAMPLE SIZE AND CONTROL LIMITS USED FOR SPECIAL MANUFACTURING PROCESS MONITORING IN ALIGNMENT WITH THE STATISTICAL PROCESS CONTROL PROGRAM AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN VILLALBA, PUERTO RICO.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |