PMA N17600S030

Device: Avitene Microfibrillar Collagen Hemostat (MCH)
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S030
Product code: LMF
Decision date: 2018-08-01
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Alternate in-process test method and test equipment (digital meter) used for % Ethanol determination during AviteneTM Microfibrillar Collagen Hemostat bulk flour production.

Current openFDA PMA Record#

Device: Avitene Microfibrillar Collagen Hemostat (MCH)
Applicant: Davol Inc., Sub. C. R. Bard, Inc.
PMA number: N17600
Supplement: S030
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2018-08-01
Decision code: OK30
Date received: 2018-06-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternate in-process test method and test equipment (digital meter) used for % Ethanol determination during AviteneTM Microfibrillar Collagen Hemostat bulk flour production.