Approval for replacement resin for the manufacturing of "heat shrink" tubing used in all sizes of the dcyl 200 series fibers (dcyl 210, 215,220,225, 250).
| Device | OPTIGUIDE Fiber Optic Diffuser (DCYL Cylindrical Diffuser Series) |
| Classification Name | System, Laser, Fiber Optic, Photodynamic Therapy |
| Generic Name | System, Laser, Fiber Optic, Photodynamic Therapy |
| Applicant | CONCORDIA LABORATORIES, INC |
| Date Received | 2017-10-24 |
| Decision Date | 2018-01-17 |
| PMA | P940010 |
| Supplement | S012 |
| Product Code | MVG |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |
|---|
| 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