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) | 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.
 
DeviceMENTOR POLYTEF PASTE /FOR INJECTION
Generic NamePASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
ApplicantColoplast Corp.
1601 W. River Rd. N.
Plymouth, MN 55411
PMA NumberN16420
Supplement NumberS006
Date Received10/26/2001
Decision Date11/21/2001
Withdrawal Date10/02/2009
Product Code LTG 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR RELOCATION OF THE FORMULATION OF THE BULK PASTE AND THE EQUIPMENT AND PROCESSES ASSOCIATED WITH COMPOUNDING TO MENTOR, MINEAPOLIS, MINNISOTA.
-
-