- Device
- Micra™ Scalable Catheter Delivery System (Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S224
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2026-06-04
- Decision code
- APPR
- Date received
- 2026-03-06
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for design and subsequent process changes to the Micra™ Delivery Catheter contained within the Micra Transcatheter Pacing System (TPS).