DIOMED 630 PDT LASER

System, Laser, Photodynamic Therapy

FDA Premarket Approval P990021

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

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

• Device: DIOMED 630 PDT LASER
• Classification Name: System, Laser, Photodynamic Therapy
• Generic Name: System, Laser, Photodynamic Therapy
• Applicant: CONCORDIA LABORATORIES, INC
• Date Received: 1999-05-04
• Decision Date: 2000-06-30
• Notice Date: 2000-07-14
• PMA: P990021
• Supplement: S
• Product Code: MVF
• Docket Number: 00M-1387
• Advisory Committee: General & Plastic Surgery
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: CONCORDIA LABORATORIES, INC 5 Canewood Industrial Park st Michael BB110
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P990021		Original Filing
S005	2021-04-27	Normal 180 Day Track
S004	2017-08-02	Normal 180 Day Track
S003	2015-10-06	Normal 180 Day Track
S002	2009-05-26	Real-time Process
S001	2002-06-12	Panel Track

NIH GUDID Devices

Device ID	PMA	Supp
00376128000179	P990021	003
00376128000155	P990021	003
00376128000179	P990021	004
00376128000193	P990021	005