PMA P230035S001

Device: AGENT Paclitaxel-Coated Balloon Catheter
Applicant: Boston Scientific Corporation
PMA number: P230035
Supplement: S001
Product code: OOB
Decision date: 2024-04-11
Classification: Cardiovascular
Generic name: Drug-eluting percutaneous transluminal coronary angioplasty catheter
Approval order statement: approval of the 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 P230025.

Current openFDA PMA Record#

Device: AGENT Paclitaxel-Coated Balloon Catheter
Applicant: Boston Scientific Corporation
PMA number: P230035
Supplement: S001
Product code: OOB
Generic name: Drug-eluting percutaneous transluminal coronary angioplasty catheter
Decision date: 2024-04-11
Decision code: APPR
Date received: 2024-03-14
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the 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 P230025.