• 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 has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceVITAGEL RT3 SUTGICAL HEMOSTAT
Classification Nameabsorbable collagen hemostatic agent with thrombin
Generic Nameabsorbable collagen hemostatic agent with thrombin
Regulation Number878.4490
Applicant
STRYKER CORP.
2825 airview boulevard
portage, MI 49002
PMA NumberP050044
Date Received11/30/2005
Decision Date06/16/2006
Product Code
PMX[ Registered Establishments with PMX ]
Docket Number 06M-0293
Notice Date 07/26/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the vitagel surgical hemostat. The device is indicated for use in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S021 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 
-
-