KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
FDA premarket approval P050027/S005 · decided 2013-09-23
Approval details
- PMA number
- P050027
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2013-03-18
- Decision date
- 2013-09-23
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT KARL STORZ GMBH & CO., IN TUTTLINGEN, GERMANY TO MANUFACTURE THE C LIGHT SOURCE.
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