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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.
 
DeviceVITAGEL RT3 DELIVERY SYSTEM
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantSTRYKER CORP.
2825 AIRVIEW BOULEVARD
PORTAGE, MI 49002
PMA NumberP050044
Supplement NumberS028
Date Received03/07/2014
Decision Date06/05/2014
Withdrawal Date 07/10/2019
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES TO THE BA-02 DELIVERY SYSTEM COMPONENT OF VITAGEL RT3 SURGICAL HEMOSTAT: REPLACEMENT OF THE CURRENT SYRINGE CLIP AND SYRINGE SUPPORT COMPONENTS WITH A TWIN SYRINGE DISPENSER, REPLACEMENT OF THE CURRENT JOINER COMPONENT WITH A ROTATING LUER ADAPTER (SYRINGE ADAPTER) TO THE DISTAL LUER CONNECTIONS OF THE EXTENDED APPLICATORS, CHANGES IN MATERIALS OF CONSTRUCTION AND MANUFACTURERS OF THE AFOREMENTIONED COMPONENTS AND UPDATE IN THE PRIMARY PACKAGING. ADDITIONALLY, THE OPTIONAL EXTENDED APPLICATOR DELIVERY ACCESSORIES OF THE VITAGEL RT3 SURGICAL HEMOSTAT, MALLEABLE EXTENDED APPLICATOR (MEA) AND LAPAROSCOPIC EXTENDED APPLICATOR (LEA), AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES REACH 9 MALLEABLE APPLICATOR AND REACH 38 LAPAROSCOPIC APPLICATOR, RESPECTIVELY.
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