KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
FDA premarket approval P050027/S014 · decided 2019-02-21
Approval details
- PMA number
- P050027
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2018-09-17
- Decision date
- 2019-02-21
- Days to decision
- 157 days
- Decision code
- APPR
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- Approval for the following alternate sterilization methods for the Flexible PDD Video Cystoscopes (P/N: 11272VNIA and 11272VNIUA): STERRAD NX Advanced Cycle, STERRAD 100 NX Flex and Duo Cycles, STERIS V-PRO maX Flexible Cycle and Steris V-PRO 60 Flexible Cycle.
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