Karl Storz Photodynamic D-light C (PDD) System
FDA premarket approval P050027/S018 · decided 2019-12-20
Approval details
- PMA number
- P050027
- Supplement
- S018
- 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
- 2019-05-30
- Decision date
- 2019-12-20
- Days to decision
- 204 days
- Decision code
- APPR
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- Approval for a change to the light output spectral analysis measuring method of the D-Light C Light Source
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