Skip to content

EDAP LT.02 Shock Wave Lithotripter

by Edap International Corp.

PMA P880042

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 12 Dec 1991

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United StatesFDA PMAAPWD Approval withdrawn NumberP880042 Date12 Dec 1991Approval withdrawnStatusWithdrawn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  • Withdrawn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United States — FDA PMA Withdrawn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

Trade Name
Edap LT.01 Shock Wave Lithotripter
Generic Name
Lithotriptor, extracorporeal shock-wave, urological
PMA Number
FDA Product Code
LNS
Device Class
Class II
Regulation
21 CFR Part 876.5990
Advisory Committee
Gastroenterology, Urology
FDA Decision
APWD Approval withdrawn

Other devices from Edap International Corp.

  • Sonolith 2000

    Class II