PMA supplement

P880047 S008: INTERCEED (TC7) ABSORBABLE ADHESION BARRIER

FDA PMA supplement · Normal 180 Day Track No User Fee · ETHICON, Inc.

Key facts

Original PMA P880047
Supplement number S008
Supplement type Normal 180 Day Track No User Fee
Reason for the supplement Express GMP Supplement
Trade name INTERCEED (TC7) ABSORBABLE ADHESION BARRIER
Generic name Barrier, absorbable, adhesion
Applicant ETHICON, Inc.
Product code MCN
Received date Sep 4, 2003
Decision date Oct 21, 2003

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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