PMA P890003S304
- Device
- REVEAL LINQ SOFTWARE MODEL SWO26
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S304
- Product code
- OSR
- Decision date
- 2014-04-30
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- APPROVAL FOR MODEL SW026 APPLICATION SOFTWARE FOR THE REVEAL LINQ IMPLANTABLE CARDIAC MONITORS USED ON THE MODEL 2090 AND ENCORE PROGRAMMERS.
Current openFDA PMA Record#
- Device
- REVEAL LINQ SOFTWARE MODEL SWO26
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S304
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2014-04-30
- Decision code
- APPR
- Date received
- 2014-03-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODEL SW026 APPLICATION SOFTWARE FOR THE REVEAL LINQ IMPLANTABLE CARDIAC MONITORS USED ON THE MODEL 2090 AND ENCORE PROGRAMMERS.