PMA P140017S030

Device: MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)
Applicant: Medtronic, Inc.
PMA number: P140017
Supplement: S030
Product code: NPV
Decision date: 2025-03-27
Classification: Cardiovascular
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: layout changes, maximum personnel occupancy increase in the main room and fixation room, and additional microbial air monitoring points and surface monitoring points

Current openFDA PMA Record#

Device: MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)
Applicant: Medtronic, Inc.
PMA number: P140017
Supplement: S030
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2025-03-27
Decision code: OK30
Date received: 2025-02-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: layout changes, maximum personnel occupancy increase in the main room and fixation room, and additional microbial air monitoring points and surface monitoring points