InterStim Therapy System, Verify Evaluation System (SNS Urinary)
FDA premarket approval P970004/S336 · decided 2021-07-15
Approval details
- PMA number
- P970004
- Supplement
- S336
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim Therapy System, Verify Evaluation System (SNS Urinary)
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-07-08
- Decision date
- 2021-07-15
- Days to decision
- 7 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Use additional existing sealer tray machines and to update applicable procedures to include validated sealing and peel strength testing parameters on the Sterile Pack Manufacturing Line.
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 |