PMA P050027S004

Device: KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S004
Product code: OAY
Decision date: 2012-09-10
Classification: Light Source System, Diagnostic Endoscopic
Generic name: Light source system, diagnostic endoscopic
Approval order statement: APPROVAL OF CORRECTIONS TO THE ETHYLENE OXIDE (ETO) STERILIZATION INSTRUCTIONS CONTAINED IN THE PDD CAMERA HEADS INSTRUCTION CARD, HOPKINS II PDD TELESCOPES INSTRUCTION MANUAL AND TRICAM SL II CAMERA CONTROL UNIT INSTRUCTION MANUAL.

Current openFDA PMA Record#

Device: KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S004
Product code: OAY
Generic name: Light source system, diagnostic endoscopic
Decision date: 2012-09-10
Decision code: APPR
Date received: 2012-08-21
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL OF CORRECTIONS TO THE ETHYLENE OXIDE (ETO) STERILIZATION INSTRUCTIONS CONTAINED IN THE PDD CAMERA HEADS INSTRUCTION CARD, HOPKINS II PDD TELESCOPES INSTRUCTION MANUAL AND TRICAM SL II CAMERA CONTROL UNIT INSTRUCTION MANUAL.