KARL STORZ D-Light C PDD System
FDA premarket approval P050027/S031 · decided 2023-05-05
Approval details
- PMA number
- P050027
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- KARL STORZ D-Light C PDD System
- Generic name
- Light source system, diagnostic endoscopic
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2023-04-06
- Decision date
- 2023-05-05
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- Change in supplier of three subassembly components used in the Karl Storz PDD System.
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