PMA P050044S028
- Device
- VITAGEL RT3 DELIVERY SYSTEM
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S028
- Product code
- LMF
- Decision date
- 2014-06-05
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- 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.
Current openFDA PMA Record#
- Device
- VITAGEL RT3 DELIVERY SYSTEM
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S028
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2014-06-05
- Decision code
- APPR
- Date received
- 2014-03-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.