PMA P810006S086

Device: Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Hemostatic Agent - Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
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: Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Hemostatic Agent - Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
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.