• 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 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.
 
DeviceSALINE-FILLED MAMMARY PROSTHESIS AND SPECTRUM POST-OPERATIVELY ADJUSTABLE SALINE-FILLED MAMMARY PROSTHESIS
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Nameprosthesis, breast, inflatable, internal, saline
Regulation Number878.3530
Applicant
MENTOR WORLDWIDE LLC
33 technology drive
irvine, CA 92618
PMA NumberP990075
Supplement NumberS016
Date Received06/27/2005
Decision Date07/27/2005
Product Code
FWM[ Registered Establishments with FWM ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) new style 2000 moderate plus profile, which is considered a modification to the existing product ine, with sizes 175cc-800cc; 2) additional sizes of 400cc, 450cc, 500cc, 600cc, 650cc and 800cc for style 1600; and 3) additional sizes of 350cc, 400cc, 700cc, 770cc, and 800cc for style 3000. There are no changes to the indications for use.
-
-