PMA P180029S020

Device: LOTUS Edge Valve System
Applicant: Boston Scientific Corporation
Product code: NPT
Decision date: 2020-08-17
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Approval for implementation of a Visual Standard to aid operators in distinguishing between acceptable and rejectable surface defects on the Multi-Lumen Extrusion (MLE) of the Lotus Edge Valve System.

Current openFDA PMA Record#

Device: LOTUS Edge Valve System
Applicant: Boston Scientific Corporation
PMA number: P180029
Supplement: S020
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2020-08-17
Decision code: APPR
Date received: 2020-03-02
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for implementation of a Visual Standard to aid operators in distinguishing between acceptable and rejectable surface defects on the Multi-Lumen Extrusion (MLE) of the Lotus Edge Valve System.