SPINAL CORD STIMULATION EXTENSION MODELS 37081, 37082 AND 37083
FDA premarket approval P840001/S221 · decided 2012-09-14
Approval details
- PMA number
- P840001
- Supplement
- S221
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPINAL CORD STIMULATION EXTENSION MODELS 37081, 37082 AND 37083
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2012-07-16
- Decision date
- 2012-09-14
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MINOR MODIFICATIONS TO THE PACKAGE DIMENSIONS, THE INNER TRAY AND THE RETAINER LID. ALSO REQUESTED WAS A PACKAGE MATERIAL CHANGE FROM POLYVINYL CHLORIDE (PVC) TO POLYETHYLENE TEREPHTHALATE GLYCOL (PETG) FOR THE OUTER TRAY, THE INNER TRAY AND THE RETAINER LID.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |