MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) APPLICATION SOFTWARE MODEL 9809
FDA premarket approval P890003/S095 · decided 2005-11-22
Approval details
- PMA number
- P890003
- Supplement
- S095
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) APPLICATION SOFTWARE MODEL 9809
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2005-10-19
- Decision date
- 2005-11-22
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A SOFTWARE UPDATE, SOFTWARE SERIES 5.0 TO SOFTWARE SERIES 6.0, TO CORRECT A MINOR CUSTOMER INCONVENIENCE ANOMALY WITH TELEMETRY ERROR CONDITIONS RELATED TO THE RETRY STRATEGY BY ADDITION OF AN ENHANCEMENT CHECK TO ENSURE THAT ALL OF THE EVENT DATA HAS BEEN RECEIVED.
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510(k) clearances by this applicant
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