PMA P050027

Device
Photodynamic Diagnostic D-Light C (PDD) System
Applicant
KARL STORZ Endoscopy-America, Inc.
PMA number
P050027
Supplement
S030
Product code
OAY
Decision date
2026-02-26
Generic name
Light source system, diagnostic endoscopic
Approval order statement
specification for Photodynamic Diagnostic D-Light C (PDD) System light cables

Current openFDA PMA Record#

Device
Photodynamic Diagnostic D-Light C (PDD) System
Applicant
KARL STORZ Endoscopy-America, Inc.
PMA number
P050027
Supplement
S035
Product code
OAY
Generic name
Light source system, diagnostic endoscopic
Decision date
2026-02-26
Decision code
APPR
Date received
2026-01-29
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
specification for Photodynamic Diagnostic D-Light C (PDD) System light cables