PMA P050044S025

Device: VITAGEL RT3 SURGICAL HEMOSTAT
Applicant: Stryker Corp.
PMA number: P050044
Supplement: S025
Product code: LMF
Decision date: 2013-11-15
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR A DEVICE NAME CHANGE FOR THE VITAGEL RT SURGICAL HEMOSTAT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL RT3 SURGICAL HEMOSTAT WITH NO CHANGE IN THE INDICATIONS FOR USE.

Current openFDA PMA Record#

Device: VITAGEL RT3 SURGICAL HEMOSTAT
Applicant: Stryker Corp.
PMA number: P050044
Supplement: S025
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2013-11-15
Decision code: APPR
Date received: 2013-10-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A DEVICE NAME CHANGE FOR THE VITAGEL RT SURGICAL HEMOSTAT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL RT3 SURGICAL HEMOSTAT WITH NO CHANGE IN THE INDICATIONS FOR USE.