INTERSTIM THERAPY FOR URINARY CONTROL
FDA premarket approval P970004/S024 · decided 2003-04-01
Approval details
- PMA number
- P970004
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERSTIM THERAPY FOR URINARY CONTROL
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2003-03-07
- Decision date
- 2003-04-01
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL TO LIMIT USE OF THE MODEL 8870 APPLICATION CARD TO ONLY THE INTERSTIM AND ENTERRA APPLICATIONS BY MODIFYING THE DESKTOP SOFTWARE, TO REMOVE THE MODEL 8529 MAGNET USED WITH THE SYNCHROMED DRUG PUMP APPLICATION FROM THE PROGRAMMING UNIT, AND TO MODIFY THE LABELING TO REFLECT THESE CHANGES.
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 |