INTERSTIM IMPLANTABLE NEUROSTIMULATOR
FDA premarket approval P970004/S092 · decided 2010-10-01
Approval details
- PMA number
- P970004
- Supplement
- S092
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTERSTIM IMPLANTABLE NEUROSTIMULATOR
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2010-08-31
- Decision date
- 2010-10-01
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ADDITION OF AN ALTERNATE VENDOR FOR THE PRINTED WIRING BOARDS (PWBS) AND MANUFACTURING CHANGES FOR PWB COMPONENTS.
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 |