Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: 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.
 
DeviceKARL STORZ Photodynamic Diagnostic D-Light C (PDD) System
Generic NameLight source system, diagnostic endoscopic
ApplicantKARL STORZ Endoscopy-America, Inc.
2151 E. Grand Ave.
El Segundo, CA 90245
PMA NumberP050027
Supplement NumberS033
Date Received04/16/2025
Decision Date05/02/2025
Product Code OAY 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
changes to remove the vibratory grinding step, changing to the polishing tool for the telescope lens, process changes to the camera head housing and strain relief with the aluminum material
-
-