KARL STORZ Photodynamic D-Light C PDD System
FDA premarket approval P050027/S021 · decided 2020-06-05
Approval details
- PMA number
- P050027
- Supplement
- S021
- Supplement type
- 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
- 2020-05-08
- Decision date
- 2020-06-05
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- Manufacturing change to add a filtered air brush that uses compressed air as an alternative to canned air for cleaning the Tricam Pendulum camera head.
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