PMA P990027S020

Device: TECHNOLAS 217A EXCIMER LASER SYSTEM FOR LASER IN-SITU KERATOMILEUSIS(LASIK), TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALI
Applicant: Technolas Perfect Vision GmbH
PMA number: P990027
Supplement: S020
Product code: LZS
Decision date: 2015-11-05
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: THE REPLACEMENT OF THE SUPPLIER OF ONE COMPONENT OF YOUR TREATMENT CARD BY TWO OTHER SUPPLIERS.

Current openFDA PMA Record#

Device: TECHNOLAS 217A EXCIMER LASER SYSTEM FOR LASER IN-SITU KERATOMILEUSIS(LASIK), TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALI
Applicant: Technolas Perfect Vision GmbH
PMA number: P990027
Supplement: S020
Product code: LZS
Generic name: Excimer laser system
Decision date: 2015-11-05
Decision code: OK30
Date received: 2015-10-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: THE REPLACEMENT OF THE SUPPLIER OF ONE COMPONENT OF YOUR TREATMENT CARD BY TWO OTHER SUPPLIERS.