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GenESA System

by Gensia, Inc.

PMA P940001

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 12 Sep 1997

PMA

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP940001 Date12 Sep 1997Approval withdrawnStatusWithdrawn

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Full name
Genesa(R) System
Generic Name
Pump, drug administration, closed loop
PMA Number
FDA Product Code
MQT
Device Class
Class III
Advisory Committee
General Hospital
FDA Decision
APWD Approval withdrawn