Karl Storz D-Light C PDD System
FDA premarket approval P050027/S011 · decided 2018-02-15
Approval details
- PMA number
- P050027
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Karl Storz D-Light C PDD System
- Generic name
- Light source system, diagnostic endoscopic
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2017-08-03
- Decision date
- 2018-02-15
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- Approval for additional subsystem and manufacturing site.
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