• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device mesh, surgical, non-synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
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 and uterine prolapse repair completed transvaginally.
Product CodePAI
Regulation Number 884.5980
Device Class 3


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
TISSUE SCIENCE LABORATORIES, PLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 25
No Information 3
Extrusion 1
Total Device Problems 29

-
-