REVO MRI SURESCAN PACING SYSTEM
FDA premarket approval P090013/S013 · decided 2011-05-27
Approval details
- PMA number
- P090013
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REVO MRI SURESCAN PACING SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2011-03-29
- Decision date
- 2011-05-27
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODEL 2490G (VERSION 9V5) MEDTRONIC CARELINK MONITOR AND MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (REVO MRI SW018 XMLTU AND ENRHYTHM MRI V7.3 SW005 XMLTU).
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