MEDTRONIC INTERSTIM THERAPY
FDA premarket approval P970004/S049 · decided 2008-04-24
Approval details
- PMA number
- P970004
- Supplement
- S049
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC INTERSTIM THERAPY
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2008-02-26
- Decision date
- 2008-04-24
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR LABELING CHANGES TO THE TECHNICAL MANUAL FOR THE TEST STIMULATION LEAD KIT AND TEST STIMULATION LEAD (MODEL 3065U AND MODEL 3057, RESPECTIVELY) TO EXPLICITLY DESCRIBE THE PRACTICE OF IMPLANTING TWO TEMPORARY TEST STIMULATION LEADS DURING A SINGLE BILATERAL PLACEMENT PROCEDURE FOR SEQUENTIAL TESTING WITHIN THE SEVEN DAY TRIAL PERIOD.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |