KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
FDA premarket approval P050027/S004 · decided 2012-09-10
Approval details
- PMA number
- P050027
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2012-08-21
- Decision date
- 2012-09-10
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- OAY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- El Segundo, CA
- Statement
- APPROVAL OF CORRECTIONS TO THE ETHYLENE OXIDE (ETO) STERILIZATION INSTRUCTIONS CONTAINED IN THE PDD CAMERA HEADS INSTRUCTION CARD, HOPKINS II PDD TELESCOPES INSTRUCTION MANUAL AND TRICAM SL II CAMERA CONTROL UNIT INSTRUCTION MANUAL.
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