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.
 
DeviceGEL-ONE
Generic NameAcid, hyaluronic, intraarticular
ApplicantSeikagaku Corp.
6-1, Marunouchi 1-Chome,
Chiyoda-Ku
Tokyo 100-0005
PMA NumberP080020
Supplement NumberS018
Date Received08/31/2015
Decision Date11/25/2015
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE MANUFACTURING AND STORING OF GEL-ONE® TO ALLOW FOR THE REFRIGERATION (5°C ± 3°C) OF IN-PROCESS PRODUCT (I.E. PRODUCT THAT HAS NOT YET BEEN PACKAGED AND LABELED) FOR A MAXIMUM OF 6 MONTHS FOLLOWING THE DATE OF TERMINAL STEAM STERILIZATION AND PRIOR TO INITIATION OF THE PRODUCT¿S PREVIOUSLY ESTABLISHED 12 MONTH SHELF LIFE WHEN STORED BELOW 25°C (WITHOUT FREEZING).
-
-