REVO MRI IPG
FDA premarket approval P090013/S149 · decided 2015-01-26
Approval details
- PMA number
- P090013
- Supplement
- S149
- Supplement type
- Normal 180 Day Track
- 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
- 2014-07-18
- Decision date
- 2015-01-26
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MYCARELINK SMART MONITOR USED WITH THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION AND IS INDICATED FOR:PATIENT READER INDICATIONS FOR USE: THE PATIENT READER IS A PORTABLE ELECTRONIC DEVICE THAT COMMUNICATES WITH YOUR MEDTRONICIMPLANTED HEART DEVICE. THE APPLICATION ON SMART PHONE OR TABLET TRANSMITS IMPLANTED HEART DEVICE DATA TO THE MEDTRONIC CARELINK NETWORK. MOBILE APPLICATION INDICATIO
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510(k) clearances by this applicant
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|---|---|---|
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |