DIOMED 630 PDT LASER
FDA premarket approval P990021/S001 · decided 2003-08-01
Approval details
- PMA number
- P990021
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIOMED 630 PDT LASER
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 2002-06-12
- Decision date
- 2003-08-01
- Days to decision
- 415 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- APPROVAL FOR USE WITH THE PHOTOSENSITIVE DRUG PHOTOFRIN FOR THE ADDITIONAL INDICATION FOR USE FOR THE ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY.
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