Approval for revision ot the package labeling and package insert labeling. The approved modifications include clarification of directions for use and device descriptions and simplification of use of trademark or registered trademark symbols.
| Device | OPTIGUIDE CYLINDRICAL FIBER OPTIC |
| Classification Name | System, Laser, Fiber Optic, Photodynamic Therapy |
| Generic Name | System, Laser, Fiber Optic, Photodynamic Therapy |
| Applicant | CONCORDIA LABORATORIES, INC |
| Date Received | 1999-07-08 |
| Decision Date | 1999-08-13 |
| PMA | P940010 |
| Supplement | S007 |
| Product Code | MVG |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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