PMA P050027S021

Device: KARL STORZ Photodynamic D-Light C PDD System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S021
Product code: OAY
Decision date: 2020-06-05
Generic name: Light source system, diagnostic endoscopic
Approval order statement: Manufacturing change to add a filtered air brush that uses compressed air as an alternative to canned air for cleaning the Tricam Pendulum camera head.

Current openFDA PMA Record#

Device: KARL STORZ Photodynamic D-Light C PDD System
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S021
Product code: OAY
Generic name: Light source system, diagnostic endoscopic
Decision date: 2020-06-05
Decision code: OK30
Date received: 2020-05-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing change to add a filtered air brush that uses compressed air as an alternative to canned air for cleaning the Tricam Pendulum camera head.