PMA P810006S092

Device: Collastat Absorbable Collagen Hemostatic Sponge and Collasta Absorbable Collagen hemostatic Agent - Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S092
Product code: LMF
Decision date: 2021-01-19
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Split of an existing Compressed Air Point of Use to support additional packaging capacities at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.

Current openFDA PMA Record#

Device: Collastat Absorbable Collagen Hemostatic Sponge and Collasta Absorbable Collagen hemostatic Agent - Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S092
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2021-01-19
Decision code: OK30
Date received: 2020-12-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Split of an existing Compressed Air Point of Use to support additional packaging capacities at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.