PMA P050044S001

Device: VITAGEL SURGICAL HEMOSTAT
Applicant: Stryker Corp.
PMA number: P050044
Supplement: S001
Product code: LMF
Decision date: 2007-01-25
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR REVISED CELLPAKER MANUFACTURE BY SPECIAL TEAM MEDICAL SERVICES (YORBA LINDA, CALIFORNIA), TERMINAL STERILIZATION OF THE CELLPAKER BY STERIGENICS US, INC. (SAN DIEGO, CALIFORNIA), AND CHANGE IN CONTRACTOR PERFORMING THE LIMULUS AMEBOCYTE LYSATE ASSAY TO LEXAMED, LTD (TOLEDO, OHIO).

Current openFDA PMA Record#

Device: VITAGEL SURGICAL HEMOSTAT
Applicant: Stryker Corp.
PMA number: P050044
Supplement: S001
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2007-01-25
Decision code: APPR
Date received: 2006-08-08
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR REVISED CELLPAKER MANUFACTURE BY SPECIAL TEAM MEDICAL SERVICES (YORBA LINDA, CALIFORNIA), TERMINAL STERILIZATION OF THE CELLPAKER BY STERIGENICS US, INC. (SAN DIEGO, CALIFORNIA), AND CHANGE IN CONTRACTOR PERFORMING THE LIMULUS AMEBOCYTE LYSATE ASSAY TO LEXAMED, LTD (TOLEDO, OHIO).