PMA P050027S030

Device: KARL STORZ D-Light C PDD System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S030
Product code: OAY
Decision date: 2022-03-17
Generic name: Light source system, diagnostic endoscopic
Approval order statement: Manufacturing change to transfer the PDD Cystoscope Monocoil to a vertebrae weld and the PDD Cystoscope Screw Tube sub-assembly weld to be welded by the welder in the Pilot production room.

Current openFDA PMA Record#

Device: KARL STORZ D-Light C PDD System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S030
Product code: OAY
Generic name: Light source system, diagnostic endoscopic
Decision date: 2022-03-17
Decision code: OK30
Date received: 2022-02-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing change to transfer the PDD Cystoscope Monocoil to a vertebrae weld and the PDD Cystoscope Screw Tube sub-assembly weld to be welded by the welder in the Pilot production room.