MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM
FDA premarket approval P970004/S003 · decided 1998-11-02
Approval details
- PMA number
- P970004
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 1998-08-03
- Decision date
- 1998-11-02
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for marketing the Medtronic(R) Model 3057 Test Stimulation Lead Bulk Accessory/Medtronic(R) Model 3065U Test Stimulation Lead Kit for use with the Medtronic(R) Interstim(R) Continence Control System which is inidcated for the treatment of urinary urge incontinence in patients who have failed or could not tolerate more conservative treatments.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |