PMA supplement

N17600 S004: MICROFIBRILLAR COLLAGEN HEMOSTAT

FDA PMA supplement · Davol Inc., Sub. C. R. Bard, Inc.

Key facts

Original PMA N17600
Supplement number S004
Trade name MICROFIBRILLAR COLLAGEN HEMOSTAT
Generic name Agent, absorbable hemostatic, collagen based
Applicant Davol Inc., Sub. C. R. Bard, Inc.
Product code LMF
Received date Jul 21, 1980
Decision date Mar 31, 1981

At a glance

  • No Expedited review granted
  • No Approval order on file
  • No Summary of safety and effectiveness on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMA supplements

A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.

Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date:

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