REVEAL LINQ SOFTWARE MODEL SWO26
FDA premarket approval P890003/S304 · decided 2014-04-30
Approval details
- PMA number
- P890003
- Supplement
- S304
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REVEAL LINQ SOFTWARE MODEL SWO26
- Generic name
- Pacemaker/icd/crt non-implanted components
- Applicant
- Medtronic, Inc.
- Date received
- 2014-03-05
- Decision date
- 2014-04-30
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- OSR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODEL SW026 APPLICATION SOFTWARE FOR THE REVEAL LINQ IMPLANTABLE CARDIAC MONITORS USED ON THE MODEL 2090 AND ENCORE PROGRAMMERS.
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510(k) clearances by this applicant
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