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. |
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Device | VITAGEL RT3 DELIVERY SYSTEM |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | STRYKER CORP. 2825 AIRVIEW BOULEVARD PORTAGE, MI 49002 |
PMA Number | P050044 |
Supplement Number | S028 |
Date Received | 03/07/2014 |
Decision Date | 06/05/2014 |
Withdrawal Date
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07/10/2019 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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