Approval for the addition of the pb900 series to optiguide® cylindrical diffuser fiber optics. The change being made (due to addition of the fiber that is equivalent to pb200 and pb700 fibers) is in two quality control procedures to accommodate the smaller diameter of this design.
| Device | OPTIGUIDE Cylindrical Fiber Optic |
| Generic Name | System, Laser, Fiber Optic, Photodynamic Therapy |
| Applicant | Pinnacle Biologics, Inc. |
| Date Received | 2020-11-02 |
| Decision Date | 2021-02-24 |
| PMA | P940010 |
| Supplement | S017 |
| Product Code | MVG |
| 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 | Pinnacle Biologics, Inc. 2801 Lakeside Drive. Suite 210 bannockburn, IL 60015 |
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