Harmony Transcatheter Pulmonary Valve

FDA Premarket Approval P200046 S009

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 Transcatheter Pulmonary Valve
Generic NamePulmonary Valve Prosthesis Percutaneously Delivered
ApplicantMedtronic, Inc.3576 Unocal Placebuilding Asanta Rosa, CA 95403 PMA NumberP200046 Supplement NumberS009 Date Received05/16/2022 Decision Date05/23/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-16
Decision Date2022-05-23
PMAP200046
SupplementS009
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 NumberS009 Date Received05/16/2022 Decision Date05/23/2022 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  
a Reduction In Solution Volume During Tissue Fixation

Supplemental Filings

Supplement NumberDateSupplement Type
P200046Original Filing
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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