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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOXYCELL
Generic NameAgent, absorbable hemostatic, non-collagen based
Regulation Number878.4490
ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake, NJ 07417
PMA NumberN5798
Supplement NumberS007
Date Received02/16/1995
Decision Date07/24/1995
Product Code LMG 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE QUALITY CONTROL PROCEDURES FOR POST-STERILIZATION LOTS OF OXYCEL
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