PMA P050027S013

Device: KARL STORZ Photodynamic D-Light C (PDD) System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S013
Product code: OAY
Decision date: 2018-10-23
Classification: Light Source System, Diagnostic Endoscopic
Generic name: Light source system, diagnostic endoscopic
Approval order statement: Approval for the following alternate sterilization methods for the PDD Camera Heads: STERRAD NX Standard Cycle, STERRAD 100 NX Standard and Duo Cycles, V-Pro 60 Non-Lumen and Lumen Cycles.

Current openFDA PMA Record#

Device: KARL STORZ Photodynamic D-Light C (PDD) System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S013
Product code: OAY
Generic name: Light source system, diagnostic endoscopic
Decision date: 2018-10-23
Decision code: APPR
Date received: 2018-07-20
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the following alternate sterilization methods for the PDD Camera Heads: STERRAD NX Standard Cycle, STERRAD 100 NX Standard and Duo Cycles, V-Pro 60 Non-Lumen and Lumen Cycles.