RESTOREPRIME & PRIMEADVANCED IMPLANTABLE NEUROSTIMULATORS
FDA premarket approval P840001/S144 · decided 2010-01-21
Approval details
- PMA number
- P840001
- Supplement
- S144
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTOREPRIME & PRIMEADVANCED IMPLANTABLE NEUROSTIMULATORS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2009-12-23
- Decision date
- 2010-01-21
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- INCREASE IN THE PRESS FORCE USED TO FORM THE BATTERY CATHODES WHICH WILL REDUCE THE CATHODE THICKNESS VARIATION AND INCREASE THE YIELD OF THE RX1 BATTERY PRODUCTION.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |