KARL STORZ Photodynamic D-Light C PDD System
FDA premarket approval P050027/S022 · decided 2020-08-17
Approval details
- PMA number
- P050027
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2020-05-08
- Decision date
- 2020-08-17
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- Approval for increase in the tolerance of the countersink angle of the outer shell of the Grasping Mechanism of the Tricam camera heads from 82 +/-I degree to 82 +7/-3 degrees.
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