PMA P230035S002

Device: AGENT Paclitaxel-Coated Balloon Catheter
Applicant: Boston Scientific Corporation
PMA number: P230035
Supplement: S002
Product code: OOB
Decision date: 2024-06-28
Classification: Cardiovascular
Generic name: Drug-eluting percutaneous transluminal coronary angioplasty catheter
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230035

Current openFDA PMA Record#

Device: AGENT Paclitaxel-Coated Balloon Catheter
Applicant: Boston Scientific Corporation
PMA number: P230035
Supplement: S002
Product code: OOB
Generic name: Drug-eluting percutaneous transluminal coronary angioplasty catheter
Decision date: 2024-06-28
Decision code: APPR
Date received: 2024-05-31
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230035