Adding an incoming quality assurance test for shrinkage of the fiber components of the propel and propel mini products and to increase the upper limit for the inherent viscosity (iv) manufacturing lot release specification to match the upper limit for the current iv design specification.
| Device | PROPEL AND PROPEL MINI SINUS IMPLANTS |
| Classification Name | Drug-eluting Sinus Stent |
| Generic Name | Drug-eluting Sinus Stent |
| Applicant | INTERSECT ENT |
| Date Received | 2015-09-30 |
| Decision Date | 2015-10-28 |
| PMA | P100044 |
| Supplement | S019 |
| Product Code | OWO |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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