KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
FDA premarket approval P050027 · decided 2010-05-28
Approval details
- PMA number
- P050027
- Trade name
- KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
- Generic name
- Light source system, diagnostic endoscopic
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2005-07-31
- Decision date
- 2010-05-28
- Days to decision
- 1762 days
- Decision code
- APPR
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- APPROVAL FOR THE KARL STORZPHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM. THE KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHTC (PDD) SYSTEM IN COMBINATION WITH THE OPTICAL IMAGING DRUG CYSVIEW(HEXAMINOLEVULINATE HYDROCHLORIDE) FOR INTRAVESICAL SOLUTION IS INDICATED FOR PHOTODYNAMIC BLUELIGHT CYSTOSCOPY, AS AN ADJUNCT TO WHITE LIGHT CYSTOSCOPY FOR THE DETECTION OF NON-MUSCLE INVASIVEPAPILLARY CANCER OF THE BLADDER IN PATIENTS SUSPECTED OR KNOWN TO HAVE THE LESION ON THE BASIS OF A PRIOR CYSTOSCOPY.
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