SYNERGY PLUS+ (MODEL 7479) AND SYNERGY COMPACT+ (MODEL 7479B) NEUROSTIMULATION SYSTEMS
FDA premarket approval P840001/S077 · decided 2005-04-15
Approval details
- PMA number
- P840001
- Supplement
- S077
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNERGY PLUS+ (MODEL 7479) AND SYNERGY COMPACT+ (MODEL 7479B) NEUROSTIMULATION SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2004-12-02
- Decision date
- 2005-04-15
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE SYNERGY PLUS+ (MODEL 7479) AND SYNERGY COMPACT+ (MODEL 7479B) NEUROSTIMULATION SYSTEMS WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: 1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYNDROME; 3) POST LAMINECTOMY PAIN; 4) UNSUCCESSFUL DISK SURGERY; 5) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DI
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 |