• 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.
 
DeviceNATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
Classification Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Generic Nameprosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Number878.3540
Applicant
Allergan
2525 dupont dr.
irvine, CA 92612
PMA NumberP040046
Supplement NumberS015
Date Received05/17/2016
Decision Date06/13/2016
Product Code
FTR[ Registered Establishments with FTR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New style of pump to replace the pumps currently used to dispense silicone gel components from their storage drums into the mixing vessel.
-
-