BioFreedom Drug Coated Coronary Stent System
FDA premarket approval P190020 · decided 2022-04-14
Approval details
- PMA number
- P190020
- Trade name
- BioFreedom Drug Coated Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Biosensors International USA, Inc.
- Date received
- 2019-08-16
- Decision date
- 2022-04-14
- Days to decision
- 972 days
- Decision code
- APWD
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Wilmington, DE
- 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.
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