PMA supplement

P800022 S011: ZYPLAST(R)

FDA PMA supplement · Allergan

Key facts

Original PMA P800022
Supplement number S011
Trade name ZYPLAST(R)
Generic name Implant, dermal, for aesthetic use
Applicant Allergan
Product code LMH
Received date Oct 25, 1984
Decision date Jun 24, 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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