PMA P050044S024

Device
VITAGEL SURGICAL HEMOSTAT
Applicant
Stryker Corp.
PMA number
P050044
Supplement
S024
Product code
LMF
Decision date
2012-10-04
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
RELOCATE CERTAIN VITAGEL SURGICAL HEMOSTAT ASSEMBLY AND PACKAGING MANUFACTURING EQUIPMENT WITHIN THE CURRENT MANUFACTURING FACILITY.

Current openFDA PMA Record#

Device
VITAGEL SURGICAL HEMOSTAT
Applicant
Stryker Corp.
PMA number
P050044
Supplement
S024
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2012-10-04
Decision code
OK30
Date received
2012-09-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
RELOCATE CERTAIN VITAGEL SURGICAL HEMOSTAT ASSEMBLY AND PACKAGING MANUFACTURING EQUIPMENT WITHIN THE CURRENT MANUFACTURING FACILITY.