PMA N17600S031

Device

Avitene Microfibrillar Collagen Hemostat

Applicant

Davol Inc., Sub. C. R. Bard, Inc.

PMA number

N17600

Supplement

S031

Product code

LMF

Decision date

2018-12-26

Classification

Agent, Absorbable Hemostatic, Collagen Based

Generic name

Agent, absorbable hemostatic, collagen based

Approval order statement

Implement an autotitrator system to measure the in-process determination of acid content per gram of collagen and the in-process specification for residual hydrochloric acid content after acidification.

Summary

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