INTERSTIM
FDA premarket approval P080025/S037 · decided 2012-09-13
Approval details
- PMA number
- P080025
- Supplement
- S037
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTERSTIM
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2012-08-20
- Decision date
- 2012-09-13
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ADDITION OF MANUFACTURING EQUIPMENT AT YOURMPROC-JUNCOS FACILITY GERMANE TO ITREL, SYNERGY, RESTORE, SOLETRA, KINETRA, INTERSTIM AND ENTERRA NEUROSTIMULATOR.
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 |