PMA P930016S028

Device: STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S028
Product code: LZS
Decision date: 2008-04-09
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT AMP MANUFACTURING USA, LLC, MILPITAS, CALIFORNIA.

Current openFDA PMA Record#

Device: STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S028
Product code: LZS
Generic name: Excimer laser system
Decision date: 2008-04-09
Decision code: APPR
Date received: 2007-10-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT AMP MANUFACTURING USA, LLC, MILPITAS, CALIFORNIA.