| Device | BioFreedom Drug Coated Coronary Stent System |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Biosensors International USA, Inc.1013 Centre Rd.suite 228wilmington, DE 19805 PMA NumberP190020 Date Received08/16/2019 Decision Date04/14/2022 Product Code NIQ Advisory Committee Cardiovascular Clinical TrialsNCT02843633 Expedited Review Granted? No |
| Date Received | 2019-08-16 |
| Decision Date | 2022-04-14 |
| PMA | P190020 |
| Supplement | S |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Biosensors International USA, Inc. 1013 Centre Rd. suite 228 wilmington, DE 19805 PMA NumberP190020 Date Received08/16/2019 Decision Date04/14/2022 Product Code NIQ Advisory Committee Cardiovascular Clinical TrialsNCT02843633 Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval For The BioFreedom Drug Coated Stent System. This Device Is Indicated For Improving Coronary Luminal Diameter In Patients At High Risk For Bleeding With Symptomatic Ischemic Heart Disease Due To De Novo Lesions Of Length ? 32 Mm In Native Coronary Arteries With A Reference Diameter Ranging Between 2.25 Mm And 4.0 Mm. Supplements: |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190020 | Original Filing |