NEUROSTIMULATOR IMPANTABLE INTERSTIM FAMILY
FDA premarket approval P970004/S142 · decided 2012-10-10
Approval details
- PMA number
- P970004
- Supplement
- S142
- Supplement type
- 30-Day Notice
- Trade name
- NEUROSTIMULATOR IMPANTABLE INTERSTIM FAMILY
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2012-09-10
- Decision date
- 2012-10-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- USE OF THE NEW AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER SOFTWARE RELEASE, INTERFACING WITH THE MANUFACTURING EXECUTION SYSTEM AT THE HYBRID COMPONENT SUPPLIER.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |