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 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.
 
DeviceHELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO, NJ 08540
PMA NumberP850010
Date Received02/20/1985
Decision Date11/08/1985
Product Code LMF 
Docket Number 85M-0557
Notice Date 01/02/1986
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements: S001 S002 S003 S004 S005 S006 S007 S010 S011 S012 S013 S014 
 S015 S071 S049 S053 S054 S042 S043 S044 S045 S020 S025 
S016 S026 S027 S018 S019 S017 S075 S031 S032 S033 S034 S055 
S056 S058 S059 S060 S061 S062 S035 S036 S037 S038 S039 S040 
S041 S046 S047 S048 S057 S067 S063 S064 S050 S051 S052 S028 
S021 S029 S022 S023 S024 S030 S069 S070 S074 S073 S072 S089 
S085 S086 S087 S088 S090 S092 S093 S098 S103 S106 S095 S096 
S081 S076 S080 S078 S079 S077 S084 S082 S083 S107 S108 S104 
S105 S100 S101 S102 S094 S097 S099 S091 S109 
-
-