(469 days)
The Vipon tampon is indicated for females to absorb menstrual fluid and/or other vaginal discharge.
Not Found
This is a medical device approval letter from the FDA for the Vipon™ Menstrual Tampon. This document does not contain the information requested in your prompt regarding acceptance criteria and study details.
The letter confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory controls. It does not include performance data, study design, or ground truth methodology.
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).