FDA.reportPublic FDA data

PMA P850010S086

Device
Helistat and Helitene Absorbable Collagen Hemostatic Agent
Applicant
Integra LifeSciences Corporation
PMA number
P850010
Supplement
S086
Product code
LMF
Decision date
2019-04-26
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
Splitting an existing Clean Compressed Air (CCA) Point of Use (POU) within Room 105. You split the existing POU into two (2) POUs with one POU dedicated to filter integrity testing and the other POU dedicated to equipment drying.

Current openFDA PMA Record#

Device
Helistat and Helitene Absorbable Collagen Hemostatic Agent
Applicant
Integra LifeSciences Corporation
PMA number
P850010
Supplement
S086
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2019-04-26
Decision code
OK30
Date received
2019-03-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Splitting an existing Clean Compressed Air (CCA) Point of Use (POU) within Room 105. You split the existing POU into two (2) POUs with one POU dedicated to filter integrity testing and the other POU dedicated to equipment drying.