Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
OTPClass III

Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

21 CFR 884.5980 / Obstetrics/Gynecology

OTP is the FDA product code for Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed, a class III device type, regulated under 21 CFR 884.5980. FDA's definition for this code reads: "Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally". As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OTP
Device name
Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
FDA definition
Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally
Regulation
21 CFR 884.5980
Device class
Class III
Review panel
Obstetrics/Gynecology
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
31
Ingested recalls
0

Clearances, product code OTP

By decision year
31 clearances under product code OTP with a decision year between 2003 and 2012, 2008 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code OTP by decision year
YearClearances
20031
20043
20052
20074
20088
20096
20115
20122

Applicants with the most clearances

Product code OTP

Companies listing this code with FDA

Companies whose registered establishments list this code