INTERSTIM II
FDA premarket approval P970004/S126 · decided 2011-12-28
Approval details
- PMA number
- P970004
- Supplement
- S126
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTERSTIM II
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2011-12-08
- Decision date
- 2011-12-28
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- UPGRADE AND USE VERSION 6.4 OF THE HYBRID SLANT HANDLER SOFTWARE AT MEDTRONIC¿S HYBRID SUPPLIER.
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 |