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.
| Device | PHOTOFRIN 630 PDT Laser |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | Pinnacle Biologics, Inc.2801 Lakeside Drive. Suite 210bannockburn, IL 60015 PMA NumberP990021 Supplement NumberS005 Date Received04/27/2021 Decision Date03/02/2022 Product Code MVF Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2021-04-27 |
| Decision Date | 2022-03-02 |
| PMA | P990021 |
| Supplement | S005 |
| 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 | Pinnacle Biologics, Inc. 2801 Lakeside Drive. Suite 210 bannockburn, IL 60015 PMA NumberP990021 Supplement NumberS005 Date Received04/27/2021 Decision Date03/02/2022 Product Code MVF Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval For PHOTOFRIN® 630 PDT Laser, Model BWF5-630-2-PI (an Updated Design Of The Currently Marketed Laser, The DIOMED 630 PDT Laser, Model T2USA), And B&W TEK Inc., Located At 18 Shea Way, Suite 103, Newark, DE, 19713 As The New Manufacturing Site Of The PHOTOFRIN® 630 PDT Laser, Model BWF5-630-2-PIN. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00376128000179 | P990021 | 003 |
| 00376128000155 | P990021 | 003 |
| 00376128000179 | P990021 | 004 |
| 00376128000193 | P990021 | 005 |