MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) WITH UPDATED TO THE APPLICATION SOFTWARE (MODEL 09-9 SERIES 2.0)
FDA premarket approval P890003/S062 · decided 2001-05-07
Approval details
- PMA number
- P890003
- Supplement
- S062
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) WITH UPDATED TO THE APPLICATION SOFTWARE (MODEL 09-9 SERIES 2.0)
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2001-04-11
- Decision date
- 2001-05-07
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC MODEL 9809 SERIES 2.0 SOFTWARE FOR USE WITH THE MEDTRONIC MODEL 9790 PROGRAMMER SERIES FOR USE IN PROGRAMMING THE MODEL 9526 REVEAL IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR.
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