REVO MRI SURESCAN IPG AND PACING SYSTEM
FDA premarket approval P090013/S301 · decided 2020-04-23
Approval details
- PMA number
- P090013
- Supplement
- S301
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REVO MRI SURESCAN IPG AND PACING SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2019-07-01
- Decision date
- 2020-04-23
- Days to decision
- 297 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for Cobalt XT, Cobalt, and Crome MRI SureScan Implantable Cardioverter Defibrillator (ICD) and ICD with Cardiac Resynchronization Systems.
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