Restore, Itrel®, Synergy® and Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris Sp
FDA premarket approval P840001/S500 · decided 2022-02-18
Approval details
- PMA number
- P840001
- Supplement
- S500
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Restore, Itrel®, Synergy® and Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris Sp
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-09-07
- Decision date
- 2022-02-18
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the use of electronic labeling as a primary medium for distributing Neuromodulation and Pelvic Health product labeling to patients.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |