Karl Storz D-Light C PDD System

Light Source System, Diagnostic Endoscopic

FDA Premarket Approval P050027 S011

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

Approval for additional subsystem and manufacturing site.

DeviceKarl Storz D-Light C PDD System
Classification NameLight Source System, Diagnostic Endoscopic
Generic NameLight Source System, Diagnostic Endoscopic
ApplicantKARL STORZ ENDOSCOPY-AMERICA, INC.
Date Received2017-08-03
Decision Date2018-02-15
PMAP050027
SupplementS011
Product CodeOAY
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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
S030 2022-02-16 30-day Notice
S029 2021-09-09 30-day Notice
S028
S027 2020-12-10 30-day Notice
S026 2020-12-09 30-day Notice
S025 2020-06-29 30-day Notice
S024
S023
S022
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

NIH GUDID Devices

Device IDPMASupp
04048551423547 P050027 000
04048551063910 P050027 000
04048551064092 P050027 000
04048551073094 P050027 000
04048551073131 P050027 000
04048551073209 P050027 000
04048551289532 P050027 000
04048551402528 P050027 000
04048551402535 P050027 000
04048551423516 P050027 000
04048551004654 P050027 000
04048551350652 P050027 001
04048551064160 P050027 001

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