PMA P150033S070
- Device
- Micra Transcatheter Pacing System
- Applicant
- Medtronic, Inc.
- Product code
- PNJ
- Decision date
- 2020-06-17
- Generic name
- Leadless pacemaker
- Approval order statement
- Approval to pool existing usable M-PREP treadmill test data from the Micra IDE, China IDE, and the Micra rate response study.
Current openFDA PMA Record#
- Device
- Micra Transcatheter Pacing System
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S070
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2020-06-17
- Decision code
- APPR
- Date received
- 2020-04-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval to pool existing usable M-PREP treadmill test data from the Micra IDE, China IDE, and the Micra rate response study.