• 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 NameMENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Generic Namesilicone gel-filled breast implant
Regulation Number878.3540
ApplicantMENTOR CORP.
PMA NumberP030053
Supplement NumberS004
Date Received03/27/2007
Decision Date04/27/2007
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to revise the post-approval study to allow for the voluntary rather than mandatory participation of all patients, irrespective of the type of implant (i. E. , memorygel implant or saline implants) they receive.
-
-