PMA supplement

N80838 S008: SUPRAMID EXTRA SUTURES

FDA PMA supplement · S. Jackson, Inc.

Key facts

Original PMA N80838
Supplement number S008
Trade name SUPRAMID EXTRA SUTURES
Generic name Suture, nonabsorbable, synthetic, polyamide
Applicant S. Jackson, Inc.
Product code GAR
Received date Mar 27, 1985
Decision date May 17, 1985

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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