PMA P810006S068

Device: COLLASTA ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S068
Product code: LMF
Decision date: 2016-03-29
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Approval for a change to the collagen processing equipment cleaning protocol.

Current openFDA PMA Record#

Device: COLLASTA ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S068
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2016-03-29
Decision code: APPR
Date received: 2015-08-24
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change to the collagen processing equipment cleaning protocol.