MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM FOREMAN NEEDLE
FDA premarket approval P970004/S029 · decided 2005-08-04
Approval details
- PMA number
- P970004
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM FOREMAN NEEDLE
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2004-08-30
- Decision date
- 2005-08-04
- Days to decision
- 339 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR: 1) SHIPMENT OF PATIENT CABLE (MODEL 041831) AFTER MANUFACTURING TO MEDTRONIC NEUROLOGICAL DIVISION, SULLIVAN LAKE FACILITY, MINNEAPOLIS, MINNESOTA, FOR CLEANING, PACKAGING AND ETHYLENE OXIDE STERILIZATION, 2) EXTENSION OF THE CURRENT 2-YEAR SHELF LIFE OF THE PATIENT CABLE TO 4 YEARS USING ETHYLENE OXIDE STERILIZATION AND 3) LABELING CHANGES THAT INVOLVE COMBINING THE SEPARATE MANUALS FOR THE MODEL 3065U KIT AND THE MODEL 3057 LEAD INTO ONE MANUAL AND TO REPLACE THE COMBINED MANUAL
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| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |