FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
System, Laser, Photodynamic Therapy
PMA: P990049
·
Decision Apr 12, 2000
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- System, Laser, Photodynamic Therapy
- Trade Name
- COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM
- PMA Number
- P990049
- Device Class
- FDA Class 3
- Product Code
- MVF
- Generic Name
- SYSTEM, LASER, PHOTODYNAMIC THERAPY
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- April 12, 2000
- Date Received
- August 20, 1999
- Expedited Review
- N
- Docket Number
- 00M-1299
Advisory Committee Statement
Approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
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 |