PMA P150033S220

Device
Micra AV2 TPS; Micra VR2 TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S220
Product code
PNJ
Decision date
2026-02-10
Classification
Cardiovascular
Generic name
Leadless pacemaker
Approval order statement
a new vapor degreasing solvent

Current openFDA PMA Record#

Device
Micra AV2 TPS; Micra VR2 TPS
Applicant
Medtronic, Inc.
PMA number
P150033
Supplement
S220
Product code
PNJ
Generic name
Leadless pacemaker
Decision date
2026-02-10
Decision code
OK30
Date received
2026-01-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a new vapor degreasing solvent