MODEL 7421 ITREL 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEM
FDA premarket approval P840001/S047 · decided 2001-02-21
Approval details
- PMA number
- P840001
- Supplement
- S047
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MODEL 7421 ITREL 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2000-06-01
- Decision date
- 2001-02-21
- Days to decision
- 265 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR EXPANSION OF THE INDICATIONS FOR USE OF THE MEDTRONIC MODEL 7421 ITREL, 7424 ITREL II, 7425 ITREL III AND MODEL 7427 SYNERGY SPINAL CORD STIMULATION SYSTEMS. THESE DEVICES ARE NOW INDICATED "AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SYNDROME OR LOW BCK SYNDROME OR FAILED BACK, RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILED BACK SYND
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| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |