PMA P810006S077

Device: Collastat Absorbable Collagen Hemostatic Sponge and Agent-Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S077
Product code: LMF
Decision date: 2017-08-31
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: New Shrink Temperature Test Equipment to reduce the equipment footprint as well as to reduce background and electrical noise.

Current openFDA PMA Record#

Device: Collastat Absorbable Collagen Hemostatic Sponge and Agent-Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S077
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2017-08-31
Decision code: OK30
Date received: 2017-08-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: New Shrink Temperature Test Equipment to reduce the equipment footprint as well as to reduce background and electrical noise.