ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS
FDA premarket approval P840001/S053 · decided 2001-08-06
Approval details
- PMA number
- P840001
- Supplement
- S053
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2001-04-16
- Decision date
- 2001-08-06
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE MODEL 7495 AND MODEL 7495LZ EXTENSIONS. THE FICILITY IS LOCATED AT MEDTRONIC NEUROLOGICAL PUERTO RICO OPERATIONS, VILLALBA, PUERTO RICO.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |