INTERSTIM SYSTEM FOR URINARY CONTROL
FDA premarket approval P970004/S020 · decided 2002-02-04
Approval details
- PMA number
- P970004
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTERSTIM SYSTEM FOR URINARY CONTROL
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2002-01-16
- Decision date
- 2002-02-04
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR 1) THE ADDITION OF TEST STIMULATION CABLES TO THE EXISTING MODEL 3057 TEST STIMULATION LEAD PACKAGE AND THE MODEL 3065U TEST STIMULATION LEAD KIT, AND 2) ASSOCIATED LABELING REVISIONS TO THE MODEL 3065U INTERSTIM TEST STIMULATION LEAD KIT TECHNICAL MANUAL AND THE INTERSTIM TEST STIMULATION COMPONENTS INSTRUCTIONS FOR USE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |