Approval for modifications to the design and manufacturing of the delivery system, including the implementation of mechanical press fit bond joints, new dimensional specifications, revisions to the tip molding process, and a redefined tensile strength specification for the applicator.
| Device | Propel Contour Sinus Implant |
| Classification Name | Drug-eluting Sinus Stent |
| Generic Name | Drug-eluting Sinus Stent |
| Applicant | INTERSECT ENT |
| Date Received | 2018-11-30 |
| Decision Date | 2019-02-28 |
| PMA | P100044 |
| Supplement | S037 |
| Product Code | OWO |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | INTERSECT ENT 1555 Adams Dr menlo Park, CA 94025 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100044 | | Original Filing |
| S051 |
2022-11-25 |
30-day Notice |
| S050 |
2022-10-05 |
Special (immediate Track) |
| S049 |
2022-03-28 |
Real-time Process |
| S048 |
2021-01-11 |
Real-time Process |
| S047 | | |
| S046 |
2020-04-02 |
Real-time Process |
| S045 |
2020-03-26 |
Special (immediate Track) |
| S044 |
2019-09-10 |
30-day Notice |
| S043 | | |
| S042 |
2019-05-31 |
30-day Notice |
| S041 |
2019-05-03 |
30-day Notice |
| S040 |
2019-05-01 |
30-day Notice |
| S039 |
2019-04-26 |
30-day Notice |
| S038 | | |
| S037 |
2018-11-30 |
Real-time Process |
| S036 |
2018-10-12 |
Real-time Process |
| S035 |
2018-08-24 |
30-day Notice |
| S034 |
2018-08-08 |
30-day Notice |
| S033 |
2018-06-08 |
30-day Notice |
| S032 |
2018-05-02 |
30-day Notice |
| S031 |
2017-09-08 |
Special (immediate Track) |
| S030 |
2017-08-29 |
30-day Notice |
| S029 |
2017-05-30 |
30-day Notice |
| S028 |
2017-04-27 |
30-day Notice |
| S027 |
2017-03-01 |
Real-time Process |
| S026 |
2016-12-27 |
30-day Notice |
| S025 |
2016-09-30 |
30-day Notice |
| S024 |
2016-09-28 |
30-day Notice |
| S023 |
2016-08-01 |
Panel Track |
| S022 |
2016-06-16 |
135 Review Track For 30-day Notice |
| S021 |
2016-05-18 |
30-day Notice |
| S020 |
2016-03-25 |
Normal 180 Day Track No User Fee |
| S019 |
2015-09-30 |
30-day Notice |
| S018 |
2015-09-25 |
Panel Track |
| S017 |
2015-04-02 |
Normal 180 Day Track No User Fee |
| S016 |
2014-04-23 |
30-day Notice |
| S015 |
2014-01-16 |
30-day Notice |
| S014 |
2013-11-12 |
30-day Notice |
| S013 |
2013-11-04 |
Real-time Process |
| S012 |
2013-09-30 |
Normal 180 Day Track No User Fee |
| S011 |
2013-08-21 |
30-day Notice |
| S010 |
2013-06-25 |
Special (immediate Track) |
| S009 | | |
| S008 |
2013-03-04 |
Normal 180 Day Track No User Fee |
| S007 |
2013-01-29 |
30-day Notice |
| S006 |
2012-12-26 |
Normal 180 Day Track No User Fee |
| S005 |
2012-12-20 |
30-day Notice |
| S004 |
2012-12-14 |
Normal 180 Day Track No User Fee |
| S003 |
2012-10-01 |
Real-time Process |
| S002 |
2012-07-31 |
30-day Notice |
| S001 |
2012-03-12 |
Normal 180 Day Track |
NIH GUDID Devices