MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL
FDA premarket approval P970004 · decided 1997-09-29
Approval details
- PMA number
- P970004
- Trade name
- MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 1997-01-30
- Decision date
- 1997-09-29
- Days to decision
- 242 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- Yes
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE MEDTRONIC(R) INTERSTIM(R) SACRAL NEVE STIMULATION (SNS)(TM) SYSTEM WHICH INCLUDES THE MODEL 3886 OR 3080 LEAD, MODEL 7495 EXTENSION, MODEL 7424 IMPLANTABLE PULSE GENERATOR (IPG), MODEL 7455 MEMORY MODULE, MODEL 7432 CONSOLE PROGRAMMER, MODEL 7452 CONTROL MAGNET, MODEL 3625 TEST STIMULATOR (SCREENER), AND MODEL 3065U PNE KIT AND ACCESSORIES. THIS DEVICE IS INDICATED FOR THE TREATMENT OF URINARY URGE INCONTINENCE IN PATIENT WHO HAVE FAILED OR COULD NOT TOLERATE MORE CONSERVATIVE T
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| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |