PMA N17600S017

Device: AVITENE ULTRA FOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) SPONGE
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S017
Product code: LMF
Decision date: 2001-07-11
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE SLURRY PREPARATION AND LYOPHILIZATION PROCESS AND ADJUSTMENTS TO THE PRODUCT SPECIFICATIONS RESULTING FROM THESE MANUFACTURING CHANGES.

Current openFDA PMA Record#

Device: AVITENE ULTRA FOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) SPONGE
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S017
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2001-07-11
Decision code: APPR
Date received: 2000-12-14
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE SLURRY PREPARATION AND LYOPHILIZATION PROCESS AND ADJUSTMENTS TO THE PRODUCT SPECIFICATIONS RESULTING FROM THESE MANUFACTURING CHANGES.