Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • 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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Generic NameDevice, thermal ablation, endometrial
ApplicantGynecare, Inc.
P.O. Box 151
Somerville, NJ 08876
PMA NumberP970021
Supplement NumberS042
Date Received11/05/2014
Decision Date12/04/2014
Withdrawal Date10/25/2016
Product Code MNB 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MANUFACTURING CHANGES TO THE GYNECARE THERMACHOICE II CONTROLLER TO MEET AND COMPLY WITH THE EUROPEAN RESTRICTION OF HAZARDOUS SUBSTANCES (ROHS) DIRECTIVE2011/65/EU BY REPLACING NON-ROHS COMPLIANT COMPONENTS WITH FUNCTIONALLY EQUIVALENT ROHS COMPLIANT COMPONENTS.
-
-