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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceCOSTASIS(R)/DYNASTAT SURGICAL HEMOSTAT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Applicant
ANGIOTECH MEDICAL DEVICE TECHNOLOGIES
3600 s.w 47th avenue
gainesville, FL 32608
PMA NumberP990030
Supplement NumberS001
Date Received10/18/2000
Decision Date01/02/2001
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the method of terminal sterilization from e-beam to gamma irradiation and requested an additional 3-ml delivery syringe device with the associated labeling change.
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