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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameMENTOR SALINE-FILLED/SPECTRUM MAMMARY PROSTHESES
Classification Nameprosthesis, breast, inflatable, internal, saline
Generic Namementor saline-filled breast implants
Regulation Number878.3530
ApplicantMENTOR CORP.
PMA NumberP990075
Supplement NumberS008
Date Received05/10/2002
Decision Date06/07/2002
Product Code
FWM[ Registered Establishments with FWM ]
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 of supplier for molded silicone components to porges, division of mentor, sarlat sedex, france and a change in supplier of the raw material from dow corning to nusil for one molded component.
-
-