Approval for modification of the optiguide fiber optic diffuse to include use of a sterile, single use sheath with a reusable diffusing fiber optic. The device, as modified, will be marketed under the trade name optiguide photodynamic therapy fiber optic treatment system, series dcyl 4 and is indicated for use in photodynamic therapy with photofrin(r) (porfimer sodium) for injection for the: 1) palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physicians, cannot be satisfactorily treated with nd:yag laser therapy, 2) reduction of obsttuction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (nsclc), 3) treatment of microinvasive endobronchial nsclc in patients of whom surgery and radiotherapy are not indicated.
| Device | OPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT SYSTEM |
| Classification Name | System, Laser, Fiber Optic, Photodynamic Therapy |
| Generic Name | System, Laser, Fiber Optic, Photodynamic Therapy |
| Applicant | CONCORDIA LABORATORIES, INC |
| Date Received | 2000-04-17 |
| Decision Date | 2000-09-29 |
| PMA | P940010 |
| Supplement | S009 |
| Product Code | MVG |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CONCORDIA LABORATORIES, INC 5 Canewood Industrial Park st Michael BB110 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P940010 | | Original Filing |
| S017 |
2020-11-02 |
Real-time Process |
| S016 |
2018-12-19 |
Normal 180 Day Track |
| S015 |
2018-04-03 |
Real-time Process |
| S014 |
2018-01-16 |
30-day Notice |
| S013 |
2017-12-18 |
30-day Notice |
| S012 |
2017-10-24 |
Real-time Process |
| S011 |
2013-09-13 |
Real-time Process |
| S010 |
2002-06-12 |
Panel Track |
| S009 |
2000-04-17 |
Normal 180 Day Track |
| S008 |
1999-09-21 |
Normal 180 Day Track |
| S007 |
1999-07-08 |
Normal 180 Day Track |
| S006 |
1999-02-08 |
Normal 180 Day Track |
| S005 |
1998-08-21 |
Normal 180 Day Track |
| S004 |
1998-03-24 |
Normal 180 Day Track |
| S003 |
1997-02-18 |
Normal 180 Day Track |
| S002 |
1997-02-10 |
Normal 180 Day Track |
| S001 |
1996-07-03 |
Normal 180 Day Track |
NIH GUDID Devices