LOTUS Edge Valve System

FDA Premarket Approval P180029 S025

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Modification of uv curing parameters for the outer sheath of the lotus edge delivery system

DeviceLOTUS Edge Valve System
Generic NameAortic Valve, Prosthesis, Percutaneously Delivered
ApplicantBoston Scientific Corporation
Date Received2020-08-10
Decision Date2020-08-20
PMAP180029
SupplementS025
Product CodeNPT 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752-1234

Supplemental Filings

Supplement NumberDateSupplement Type
P180029Original Filing
S026 2020-09-14 30-day Notice
S025 2020-08-10 30-day Notice
S024 2020-06-08 30-day Notice
S023 2020-04-13 30-day Notice
S022
S021 2020-03-06 30-day Notice
S020
S019 2019-12-09 30-day Notice
S018
S017 2019-11-12 30-day Notice
S016 2019-10-15 30-day Notice
S015 2019-10-07 30-day Notice
S014 2019-09-30 30-day Notice
S013
S012 2019-09-23 30-day Notice
S011
S010 2019-08-19 30-day Notice
S009 2019-08-12 30-day Notice
S008
S007 2019-06-27 30-day Notice
S006 2019-06-17 30-day Notice
S005
S004 2019-06-03 30-day Notice
S003
S002
S001 2019-05-06 30-day Notice

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