PMA P810006S087

Device: Collastat Absorbable Collagen Hemostatic Sponge and Collstat Absorbable Collagen Hemostatic - Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S087
Product code: LMF
Decision date: 2019-05-07
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Delete select surface contact sites from Routine Environmental Monitoring for the following rooms: CMC-105 and CMC-109 at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.

Current openFDA PMA Record#

Device: Collastat Absorbable Collagen Hemostatic Sponge and Collstat Absorbable Collagen Hemostatic - Microfibrillar Form
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S087
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2019-05-07
Decision code: OK30
Date received: 2019-04-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Delete select surface contact sites from Routine Environmental Monitoring for the following rooms: CMC-105 and CMC-109 at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.