REVO MRI IPG
FDA premarket approval P090013/S124 · decided 2014-02-27
Approval details
- PMA number
- P090013
- Supplement
- S124
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REVO MRI IPG
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2013-12-19
- Decision date
- 2014-02-27
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR SOFTWARE CHANGES TO THE MYCARELINK PATIENT MONITOR M2.5 MODEL 24950 WITH MODEL 24955 RF HEAD WHICH SUPPORTS THE DEVICES AND MEDTRONIC¿S REVEAL INSERTABLE CARDIAC MONITORS MODELS 9529, 9528 AND LNQ11. THE MYCARELINK PATIENT MONITOR IS INDICATED FOR TRANSMISSION OF IMPLANTABLE DEVICE DATA TO THE CARELINK NETWORK FOR THE CLINIC TO REVIEW.
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