FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Laser, Photodynamic Therapy
PMA: P990021
·
Supplement: S001
·
Decision Aug 1, 2003
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- System, Laser, Photodynamic Therapy
- Trade Name
- DIOMED 630 PDT LASER
- PMA Number
- P990021
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- MVF
- Generic Name
- SYSTEM, LASER, PHOTODYNAMIC THERAPY
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 1, 2003
- Date Received
- June 12, 2002
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MVF | System, Laser, Photodynamic Therapy | FDA class 3 | Unknown |