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.
 
DeviceEUFLEXXA (1% SODIUM HYALURONATE)
Generic NameAcid, hyaluronic, intraarticular
ApplicantFerring Pharmaceuticals, Inc.
100 Interpace Pkwy.
Parsippany, NJ 07054
PMA NumberP010029
Supplement NumberS023
Date Received03/06/2015
Decision Date04/02/2015
Product Code MOZ 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
INCREASE IN THE PURIFICATION CAPACITY OF AN INTERMEDIATE USED IN THE MANUFACTURE OF THE EUFLEXXA PRODUCT.
-
-