INTERSTIM SYSTEM FOR URINARY CONTROL
FDA premarket approval P970004/S008 · decided 2000-03-09
Approval details
- PMA number
- P970004
- Supplement
- S008
- 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
- 2000-02-29
- Decision date
- 2000-03-09
- Days to decision
- 9 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for 1)elimination of the OR screening cable from the Model 3080 and 3886 lead kits, 2) to use the generic term "fluoropolymer" in place of "PTFE," and 3) to make numerous minor revisions to the Physician and Hospital Staff Manual for the Model 3012 Quadripolar Neurostimulator, Models 3080 and 3886 Leads, and Model 3095 Extension.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |