INTERSTIM/INTERSTIM II NEUROSTIMULATOR
FDA premarket approval P970004/S097 · decided 2010-11-24
Approval details
- PMA number
- P970004
- Supplement
- S097
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTERSTIM/INTERSTIM II NEUROSTIMULATOR
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2010-10-25
- Decision date
- 2010-11-24
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- IMPLEMENTATION OF UPDATED HARDWARE AND SOFTWARE FOR THE BARCODE/OPTICAL CHARACTER RECOGNITION LABELER SYSTEM AS WELL AS A PROCESS CHANGE PERTAINING TO THE UPGRADED LABELER SYSTEM.
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 |