DIOMED 630 PDT LASER
FDA premarket approval P990021 · decided 2000-06-30
Approval details
- PMA number
- P990021
- Trade name
- DIOMED 630 PDT LASER
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 1999-05-04
- Decision date
- 2000-06-30
- Days to decision
- 423 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- APPROVAL FOR THE DIOMED 630 PDT LASER, MODEL T2USA. THIS DEVICE IS INDICATED FOR USE IN PHOTODYNAMIC THERAPY WITH PHOTOFRIN (PORFIMER SODIUM) AS A SOURCE OF ACTIVATION OF PHOTOFRIN FOR: A) PALLIATION OF PATIENTS WITH COMPLETELY OBSTRUCTING ESOPHAGEAL CANCER, OR OF PATIENTS WITH PARTIALLY OBSTRUCTING ESOPHAGEAL CANCER WHO, IN THE OPINION OF THEIR PHYSICIAN, CANNOT BE SATISFACTORILY TREATED WITH ND:YAG LASER THERAPY. B) REDUCTION OF OBSTRUCTING AND PALLIATION OF SYMPTOMS IN PATIENTS WITH COMPLET
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