PMA P150033

Device
Micra Functional Testing on pNGHT and NGHT
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S164
Product code
PNJ
Decision date
2026-09-08
Generic name
Leadless pacemaker
Approval order statement
testing the hybrid electronic module subassemblies on a new/modified hybrid subassembly test system

Current openFDA PMA Record#

Device
Micra Functional Testing on pNGHT and NGHT
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S230
Product code
PNJ
Generic name
Leadless pacemaker
Decision date
2026-09-08
Decision code
OK30
Date received
2026-08-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
testing the hybrid electronic module subassemblies on a new/modified hybrid subassembly test system