MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL
FDA premarket approval P970004/S037 · decided 2006-08-31
Approval details
- PMA number
- P970004
- Supplement
- S037
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2006-03-06
- Decision date
- 2006-08-31
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR LABELING CHANGES TO INCORPORATION RESULTS FROM THE FIVE YEAR POST APPROVAL STUDY.
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 |