• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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 NameVITAGEL SURGICAL HEMOSTAT
Classification Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantORTHOVITA, INC.
PMA NumberP050044
Supplement NumberS005
Date Received05/19/2008
Decision Date05/30/2008
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to change the vendor of the 1 liter and 5 liter media bags used to store intermediae solutions during vitagel aseptic processing.
-
-