PMA

P840064: VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES

FDA PMA · AID, SURGICAL, VISCOELASTIC · Alcon Laboratories

Key facts

PMA number P840064
Trade name VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
Generic name AID, SURGICAL, VISCOELASTIC
Applicant Alcon Laboratories
Owner/operator Alcon Laboratories, Inc.
Product code LZP
Approval date Apr 30, 1986
Docket number 86M-0207
Notice date Jun 6, 1986
Establishment registration 1610287
FEI number 1610287

At a glance

  • 10–99 Supplements
  • Oct 1, 2026 Latest supplement decision
  • No Withdrawn
  • No Summary of safety and effectiveness on file
  • 1–9 UDI device identifiers (GUDID)
  • None MAUDE adverse event reports
  • None Recall events

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

About PMA approvals

Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.

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

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