PMA P050027S014
- Device
- KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S014
- Product code
- OAY
- Decision date
- 2019-02-21
- Classification
- Light Source System, Diagnostic Endoscopic
- Generic name
- Light source system, diagnostic endoscopic
- Approval order 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.
Current openFDA PMA Record#
- Device
- KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P050027
- Supplement
- S014
- Product code
- OAY
- Generic name
- Light source system, diagnostic endoscopic
- Decision date
- 2019-02-21
- Decision code
- APPR
- Date received
- 2018-09-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.