PMA P050027S008

Device
KARL STORZ Photodynamic D-Light C (PDD) System
Applicant
KARL STORZ Endoscopy-America, Inc.
PMA number
P050027
Supplement
S008
Product code
OAY
Decision date
2017-03-17
Classification
Light Source System, Diagnostic Endoscopic
Generic name
Light source system, diagnostic endoscopic
Approval order statement
Change of manufacturing facility.

Current openFDA PMA Record#

Device
KARL STORZ Photodynamic D-Light C (PDD) System
Applicant
KARL STORZ Endoscopy-America, Inc.
PMA number
P050027
Supplement
S008
Product code
OAY
Generic name
Light source system, diagnostic endoscopic
Decision date
2017-03-17
Decision code
OK30
Date received
2017-02-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change of manufacturing facility.