PMA P950043S005

Device: ECONOLITH(TM) LITHOTRIPTER
Applicant: Medispec, Ltd.
PMA number: P950043
Supplement: S005
Product code: LNS
Decision date: 1998-09-14
Classification: Lithotriptor, Extracorporeal Shock-wave, Urological
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order statement: Approval for relocation of manufacturing facility from Medispec, Ltd., 28 Hacharoshet T., Or-Yehuda, Israel to Medispec, Ltd., 24 Hatasiya St., Yahud, Or-Yehuda, Israel.

Current openFDA PMA Record#

Device: ECONOLITH(TM) LITHOTRIPTER
Applicant: Medispec, Ltd.
PMA number: P950043
Supplement: S005
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1998-09-14
Decision code: APRL
Date received: 1998-07-20
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for relocation of manufacturing facility from Medispec, Ltd., 28 Hacharoshet T., Or-Yehuda, Israel to Medispec, Ltd., 24 Hatasiya St., Yahud, Or-Yehuda, Israel.