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.
 
DeviceNUXFLEXXA (SODIUM HYALURONATE)
Generic NameAcid, hyaluronic, intraarticular
ApplicantFERRING PHARMACEUTICALS, INC.
100 INTERPACE PARKWAY
PARSIPPANY, NJ 07054
PMA NumberP010029
Supplement NumberS001
Date Received01/13/2005
Decision Date02/27/2006
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR 1) CHANGING THE STORAGE CONDITIONS SPECIFIED IN THE PRODUCT LABELING FROM, ?STORE IN A COLD DARK PLACE [2 ? 8 DEGREES C (36-46 DEGREES F)]. PROTECT FROM LIGHT. DO NOT FREEZE?. 2) CHANGE THE SPECIFIED SHELF LIFE TIME IN THE LABELING FORM 3 YEARS (AT REFRIGERATED TEMPERATURES) TO 12 MONTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EUFLEXXA AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN.)
-
-