PMA N17600S018

Device: AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FLOUR
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S018
Product code: LMF
Decision date: 2001-06-18
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: ELIMINATION OF CERTAIN IN PROCESS OR FINAL DEVICE TESTS PERFORMED ON AVITENE(R) COLLAGEN HEMOSTASIS (MCH) PRODUCTS. THIS WILL ELIMINATE TEST REDUNDANCY, WASTE AND/OR PROVIDE A MORE EFFICIENT UTILIZATION OF TEST SAMPLES SELECTED DURING THE PROCESSING OF AVITENE.

Current openFDA PMA Record#

Device: AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FLOUR
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S018
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2001-06-18
Decision code: OK30
Date received: 2001-05-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ELIMINATION OF CERTAIN IN PROCESS OR FINAL DEVICE TESTS PERFORMED ON AVITENE(R) COLLAGEN HEMOSTASIS (MCH) PRODUCTS. THIS WILL ELIMINATE TEST REDUNDANCY, WASTE AND/OR PROVIDE A MORE EFFICIENT UTILIZATION OF TEST SAMPLES SELECTED DURING THE PROCESSING OF AVITENE.