This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C |
| Generic Name | Drug-eluting Sinus Stent |
| Applicant | INTERSECT ENT1555 Adams Drmenlo Park, CA 94025 PMA NumberP100044 Supplement NumberS050 Date Received10/05/2022 Decision Date11/04/2022 Product Code OWO Advisory Committee Ear Nose & Throat Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-10-05 |
| Decision Date | 2022-11-04 |
| PMA | P100044 |
| Supplement | S050 |
| Product Code | OWO |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Special (immediate Track) |
| 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 PMA NumberP100044 Supplement NumberS050 Date Received10/05/2022 Decision Date11/04/2022 Product Code OWO Advisory Committee Ear Nose & Throat Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval For An Additional Control To Ensure The Spray Coaters Are Running Optimally During The Manufacturing Process. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| M927700110 | P100044 | 000 |
| 20763000710303 | P100044 | 000 |
| M927600110 | P100044 | 001 |
| 20763000710365 | P100044 | 018 |
| M927500110 | P100044 | 023 |
| 20763000710426 | P100044 | 023 |
| M927600440 | P100044 | 046 |
| 20763000710464 | P100044 | 046 |