INTERSTIM THERAPY FOR URINARY CONTROL
FDA premarket approval P970004/S073 · decided 2009-10-26
Approval details
- PMA number
- P970004
- Supplement
- S073
- Supplement type
- Normal 180 Day Track
- 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
- 2009-04-28
- Decision date
- 2009-10-26
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR CHANGES TO THE EXISTING MODEL 3093 AND MODEL 3889 INTERSTIM TINED LEADS, THE ADDITION OF AN ALTERNATIVE STYLET DESIGN TO BE INCLUDED IN THE MODEL 3093 AND MODEL 3889 LEADS KITS, AND A MINOR REVISION TO THE LABELING TO UPDATE THE LIST OF PACKAGE CONTENTS FOR THE MODEL 3093 AND MODEL 3889 LEADS KITS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |