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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDIOMED 630 PDT LASER
Classification Namesystem, laser, photodynamic therapy
Generic Namediode laser, surgical laser
ApplicantPINNACLE BIOLOGICS
PMA NumberP990021
Date Received05/04/1999
Decision Date06/30/2000
Product Code
MVF[ Registered Establishments with MVF ]
Docket Number 00M-1387
Notice Date 07/14/2000
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order 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.
Approval Order Approval Order
Supplements: S001 S002 
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