MEDTRONIC INTERSTIM THERAPY MODELS 8840 N'VISION CLINICIAN PROGRAMMER AND 8870 N'VISION APPLICATION CARD, VERSION NNB_01
FDA premarket approval P970004/S054 · decided 2008-05-30
Approval details
- PMA number
- P970004
- Supplement
- S054
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC INTERSTIM THERAPY MODELS 8840 N'VISION CLINICIAN PROGRAMMER AND 8870 N'VISION APPLICATION CARD, VERSION NNB_01
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2008-04-02
- Decision date
- 2008-05-30
- 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 PROGRAMMING GUIDE FOR MODELS 8840 NVISION CLINICIAN PROGRAMMER AND 8870 NVISION APPLICATION CARD, TO BETTER DESCRIBE HOW TO DETERMINE THE BATTERY STATUS OF THE MODEL 3058 INTERSTIM IMPLANTABLE NEUROSTIMULATOR AND FOR ADDITIONAL MINOR LABELING CHANGES.
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| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |