PMA P190020
- Device
- BioFreedom Drug Coated Coronary Stent System
- Applicant
- Biosensors International USA, Inc.
- PMA number
- P190020
- Product code
- NIQ
- Decision date
- 2022-04-14
- Generic name
- Coronary drug-eluting stent
- 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.
Current openFDA PMA Record#
- Device
- BioFreedom Drug Coated Coronary Stent System
- Applicant
- Biosensors International USA, Inc.
- PMA number
- P190020
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-04-14
- Decision code
- APWD
- Date received
- 2019-08-16
- 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