FDA.reportPublic FDA data

PMA P850010S089

Device
Helistat, Helitene Absorbable Collagen Hemaostatic Agents
Applicant
Integra LifeSciences Corporation
PMA number
P850010
Supplement
S089
Product code
LMF
Decision date
2019-06-27
Classification
Agent, Absorbable Hemostatic, Collagen Based
Generic name
Agent, absorbable hemostatic, collagen based
Approval order statement
Equipment modifications and introduction of a one-piece flow within the Cutting, Inspection and Packaging room within the Collagen Manufacturing Center located at 105 Morgan Lane, Plainsboro, New Jersey.

Current openFDA PMA Record#

Device
Helistat, Helitene Absorbable Collagen Hemaostatic Agents
Applicant
Integra LifeSciences Corporation
PMA number
P850010
Supplement
S089
Product code
LMF
Generic name
Agent, absorbable hemostatic, collagen based
Decision date
2019-06-27
Decision code
OK30
Date received
2019-05-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Equipment modifications and introduction of a one-piece flow within the Cutting, Inspection and Packaging room within the Collagen Manufacturing Center located at 105 Morgan Lane, Plainsboro, New Jersey.