PMA N17600S028

Device: AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT PRODUCT
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S028
Product code: LMF
Decision date: 2013-07-24
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR A PROPOSED RELOCATION OF RAW MATERIAL PROCESSING EQUIPMENT TO A NEW BUILDING WITHIN THE SAME RAW MATERIAL SUPPLIER ADDRESS.

Current openFDA PMA Record#

Device: AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT PRODUCT
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S028
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2013-07-24
Decision code: OK30
Date received: 2013-06-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A PROPOSED RELOCATION OF RAW MATERIAL PROCESSING EQUIPMENT TO A NEW BUILDING WITHIN THE SAME RAW MATERIAL SUPPLIER ADDRESS.