KARL STORZ Photodynamic D-Light C (PDD) System
FDA premarket approval P050027/S010 · decided 2017-11-30
Approval details
- PMA number
- P050027
- Supplement
- S010
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- KARL STORZ Photodynamic D-Light C (PDD) System
- Generic name
- Light source system, diagnostic endoscopic
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2017-06-23
- Decision date
- 2017-11-30
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- Approval for a change in measurement method used for spectral analysis of the light output of the D-Light C Light Source.
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