KARL STORZ Photodynamic D-Light C PDD System

FDA Premarket Approval P050027 S021

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

A 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

DeviceKARL STORZ Photodynamic D-Light C PDD System
Generic NameLight Source System, Diagnostic Endoscopic
ApplicantKARL STORZ ENDOSCOPY-AMERICA, INC.
Date Received2020-05-08
Decision Date2020-06-05
PMAP050027
SupplementS021
Product CodeOAY 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. Grand Ave. el Segundo, CA 90245

Supplemental Filings

Supplement NumberDateSupplement Type
P050027Original Filing
S021 2020-05-08 30-day Notice
S020 2020-02-24 30-day Notice
S019 2019-06-25 30-day Notice
S018
S017 2019-03-25 30-day Notice
S016
S015
S014 2018-09-17 Real-time Process
S013 2018-07-20 Real-time Process
S012 2018-04-23 30-day Notice
S011 2017-08-03 Normal 180 Day Track
S010 2017-06-23 135 Review Track For 30-day Notice
S009 2017-06-23 135 Review Track For 30-day Notice
S008 2017-02-15 30-day Notice
S007 2014-08-12 30-day Notice
S006 2014-07-02 30-day Notice
S005 2013-03-18 Normal 180 Day Track No User Fee
S004 2012-08-21 Special (immediate Track)
S003 2012-05-29 Real-time Process
S002 2010-09-24 Real-time Process
S001 2010-06-11 Real-time Process

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