PMA N17600S021

Device: AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) FLOUR
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S021
Product code: LMF
Decision date: 2004-10-29
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: ELIMINATION AND MODIFICATION OF THE ENDOTOXIN TESTING AND MODIFICATION OF THE LIT SEAL STRENGTH TESTING AND MODIFICATION OF THE FOIL POUCH SEAL STRENGTH TESTING.

Current openFDA PMA Record#

Device: AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) FLOUR
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S021
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2004-10-29
Decision code: OK30
Date received: 2004-10-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ELIMINATION AND MODIFICATION OF THE ENDOTOXIN TESTING AND MODIFICATION OF THE LIT SEAL STRENGTH TESTING AND MODIFICATION OF THE FOIL POUCH SEAL STRENGTH TESTING.