LOTUS Edge Valve System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Premarket Approval P180029 S017

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 new water purification system at the malaysia manufacturing facility

DeviceLOTUS Edge Valve System
Classification NameAortic Valve, Prosthesis, Percutaneously Delivered
Generic NameAortic Valve, Prosthesis, Percutaneously Delivered
ApplicantBoston Scientific Corporation
Date Received2019-11-12
Decision Date2019-11-21
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
S012 2019-09-23 30-day Notice
S010 2019-08-19 30-day Notice
S009 2019-08-12 30-day Notice
S007 2019-06-27 30-day Notice
S006 2019-06-17 30-day Notice
S004 2019-06-03 30-day Notice
S001 2019-05-06 30-day Notice

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