PMA P810006S085

Device: Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic- Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S085
Product code: LMF
Decision date: 2019-04-19
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Implementation of data integrity and security controls for the Quality Control (QC) Analytical Laboratory Instruments at the Collagen Manufacturing Center (CMC).

Current openFDA PMA Record#

Device: Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic- Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S085
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2019-04-19
Decision code: OK30
Date received: 2019-03-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of data integrity and security controls for the Quality Control (QC) Analytical Laboratory Instruments at the Collagen Manufacturing Center (CMC).