PHOTOFRIN 630 PDT Laser

System, Laser, Photodynamic Therapy

FDA Premarket Approval P990021 S004

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 photofrin 630 pdt laser to be manufactured by unionmed tech, inc. Bridgewater, new jersey.

• Device: PHOTOFRIN 630 PDT Laser
• Classification Name: System, Laser, Photodynamic Therapy
• Generic Name: System, Laser, Photodynamic Therapy
• Applicant: CONCORDIA LABORATORIES, INC
• Date Received: 2017-08-02
• Decision Date: 2018-01-17
• PMA: P990021
• Supplement: S004
• Product Code: MVF
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: CONCORDIA LABORATORIES, INC 5 Canewood Industrial Park st Michael BB110

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