KARL STORZ D-Light C PDD System
FDA premarket approval P050027/S028 · decided 2022-02-04
Approval details
- PMA number
- P050027
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- KARL STORZ D-Light C PDD System
- Generic name
- Light source system, diagnostic endoscopic
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2021-07-20
- Decision date
- 2022-02-04
- Days to decision
- 199 days
- Decision code
- APPR
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- Approval for the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) System. The device is for use in combination with the optical imaging drug Cysview® (hexaminolevulinate hydrochloride) for Intravesical Solution is indicated for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of non-muscle invasive bladder cancer, including carcinoma in situ (CIS), in patients suspected or known to have the lesion on the basis of a prior cystoscopy, or in patients u
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