• 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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePerClot® Polysaccharide Hemostatic System
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantBaxter Healthcare Corporation
25212 W. Illinois Route 120
Round Lake, IL 60073
PMA NumberP210036
Date Received10/25/2021
Decision Date05/19/2023
Product Code LMG 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT02359994
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the PerClot® Absorbable Hemostatic Powder. The device is indicated in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of suture line bleeding or capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 
-
-