PMA P050044S021

Device: VITAGEL SURGICAL HEMOSTAT
Applicant: Stryker Corp.
PMA number: P050044
Supplement: S021
Product code: LMF
Decision date: 2013-10-11
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR A NEW VERSION OF VITAGEL WHERE THE BOVINE THROMBIN COMPONENT IS REPLACED WITH RECOMBINANT HUMAN THROMBIN. THE PRODUCT, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL RT AND IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.

Current openFDA PMA Record#

Device: VITAGEL SURGICAL HEMOSTAT
Applicant: Stryker Corp.
PMA number: P050044
Supplement: S021
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2013-10-11
Decision code: APPR
Date received: 2011-10-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW VERSION OF VITAGEL WHERE THE BOVINE THROMBIN COMPONENT IS REPLACED WITH RECOMBINANT HUMAN THROMBIN. THE PRODUCT, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL RT AND IS INDICATED IN SURGICAL PROCEDURES (OTHER THAN NEUROSURGICAL AND OPHTHALMIC) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.