KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
FDA premarket approval P050027/S003 · decided 2012-08-27
Approval details
- PMA number
- P050027
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
- Generic name
- Light source system, diagnostic endoscopic
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 2012-05-29
- Decision date
- 2012-08-27
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- APPROVAL FOR AN ALTERNATE STERILIZATION METHOD, STERRAD NX, FOR THE FLUID LIGHT CABLE DEVICE COMPONENT WITHIN THE DEVICE.
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