• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Generic Namesilicone gel-filled breast implant
Regulation Number878.3540
ApplicantMENTOR WORLDWIDE LLC
PMA NumberP030053
Supplement NumberS018
Date Received07/02/2014
Decision Date07/30/2014
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to remove the in process gel cohesion test that is performed during the manufacture of the gel that is used to fill the mentor memorygel silicone gel-filled breast implants at mentor's irving, texas facility.
-
-