Harmony™ Delivery Catheter System

FDA Premarket Approval P200046 S012

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

DeviceHarmony™ Delivery Catheter System
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantMedtronic, Inc.3576 Unocal Placebuilding Asanta Rosa, CA 95403 PMA NumberP200046 Supplement NumberS012 Date Received10/31/2022 Decision Date11/01/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-31
Decision Date2022-11-01
PMAP200046
SupplementS012
Product CodeNPV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMedtronic, Inc.
3576 Unocal Place
building A
santa Rosa, CA 95403 PMA NumberP200046 Supplement NumberS012 Date Received10/31/2022 Decision Date11/01/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Automation Of A Verification Step Undertaken By Sterile Release Personnel (SRP) For Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing (BET) Prior To Final Release Of Product

Supplemental Filings

Supplement NumberDateSupplement Type
P200046Original Filing
S012 2022-10-31 30-day Notice
S011 2022-07-26 30-day Notice
S010
S009 2022-05-16 30-day Notice
S008 2022-03-11 Normal 180 Day Track No User Fee
S007 2022-02-28 30-day Notice
S006 2021-12-02 30-day Notice
S005 2021-07-09 30-day Notice
S004 2021-07-01 30-day Notice
S003
S002 2021-04-23 Special (immediate Track)
S001 2021-04-05 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00763000341367 P200046 000
00763000338992 P200046 000
00763000338985 P200046 000

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