ANGIO DYNAMICS 630PDT LASER

System, Laser, Photodynamic Therapy

FDA Premarket Approval P990021 S002

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 the use of an alternative source of laser diode and modification of the thermal management of the device.

DeviceANGIO DYNAMICS 630PDT LASER
Classification NameSystem, Laser, Photodynamic Therapy
Generic NameSystem, Laser, Photodynamic Therapy
ApplicantCONCORDIA LABORATORIES, INC
Date Received2009-05-26
Decision Date2010-10-13
PMAP990021
SupplementS002
Product CodeMVF
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.