DIOMED 630 PDT LASER

System, Laser, Photodynamic Therapy

FDA Premarket Approval P990021 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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.

DeviceDIOMED 630 PDT LASER
Classification NameSystem, Laser, Photodynamic Therapy
Generic NameSystem, Laser, Photodynamic Therapy
ApplicantCONCORDIA LABORATORIES, INC
Date Received2002-06-12
Decision Date2003-08-01
PMAP990021
SupplementS001
Product CodeMVF
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address CONCORDIA LABORATORIES, INC 5 Canewood Industrial Park st Michael BB110

Supplemental Filings

Supplement NumberDateSupplement Type
P990021Original 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 IDPMASupp
00376128000179 P990021 003
00376128000155 P990021 003
00376128000179 P990021 004
00376128000193 P990021 005
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