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Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women

FDA product code NVJ · 1 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4400
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2004-12-21 – 2004-12-21

Delivery of radio frequency energy to the submucosal tissue of the bladder neck and proximal urethra for the transurethral treatment of female stress urinary incontinence due to hypermobility.

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