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 | Stellarex 0.035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter |
| Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | The Spectranetics Corp.6531 Dumbarton Circlefremont, CA 94555 PMA NumberP160049 Supplement NumberS017 Date Received03/17/2022 Decision Date04/11/2022 Product Code ONU Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-17 |
| Decision Date | 2022-04-11 |
| PMA | P160049 |
| Supplement | S017 |
| Product Code | ONU |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | The Spectranetics Corp. 6531 Dumbarton Circle fremont, CA 94555 PMA NumberP160049 Supplement NumberS017 Date Received03/17/2022 Decision Date04/11/2022 Product Code ONU Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement introducing An Additional Sterilization Chamber For Devices Produced In Plymouth MN |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160049 | Original Filing | |
| S019 | 2022-06-14 | 30-day Notice |
| S018 | 2022-04-01 | Normal 180 Day Track No User Fee |
| S017 | 2022-03-17 | 30-day Notice |
| S016 | ||
| S015 | 2021-09-29 | Panel Track |
| S014 | ||
| S013 | 2021-09-17 | Normal 180 Day Track No User Fee |
| S012 | 2021-05-07 | Normal 180 Day Track No User Fee |
| S011 | 2021-01-21 | 30-day Notice |
| S010 | ||
| S009 | ||
| S008 | 2020-01-15 | 30-day Notice |
| S007 | 2019-09-03 | Special (immediate Track) |
| S006 | 2019-05-13 | 30-day Notice |
| S005 | 2019-04-08 | 30-day Notice |
| S004 | ||
| S003 | 2018-10-01 | Normal 180 Day Track No User Fee |
| S002 | 2018-01-22 | Real-time Process |
| S001 | 2017-09-01 | Real-time Process |