PMA P810006S035

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S035
Product code: LMF
Decision date: 2012-09-28
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: UPGRADES TO THE MEDICAL PRODUCTS MANUFACTURING SUITE.

Current openFDA PMA Record#

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S035
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2012-09-28
Decision code: OK30
Date received: 2012-08-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: UPGRADES TO THE MEDICAL PRODUCTS MANUFACTURING SUITE.