Lotus Edge Valve System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Premarket Approval P180029 S016

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

Use of a second electron beam sterilizer in tullamore ireland for sterilization of the lotus edge valve system

DeviceLotus Edge Valve System
Classification NameAortic Valve, Prosthesis, Percutaneously Delivered
Generic NameAortic Valve, Prosthesis, Percutaneously Delivered
ApplicantBoston Scientific Corporation
Date Received2019-10-15
Decision Date2019-11-12
PMAP180029
SupplementS016
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
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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