510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PAJClass II

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

PAJ is the FDA product code for Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PAJ
Device name
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
FDA definition
Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PAJ

By decision year
2 clearances under product code PAJ with a decision year between 2000 and 2005, 2000 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PAJ by decision year
YearClearances
20001
20051

Applicants with the most clearances

Product code PAJ
Applicants holding the most 510(k) clearances under product code PAJ
ApplicantClearances
Bio-Vascular, Inc.1
Integra LifeSciences Braintree Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order