REVEAL PLUS INSERTABLE LOOP RECORDER MODEL 9809 SOFTWARE
FDA premarket approval P890003/S058 · decided 1999-12-27
Approval details
- PMA number
- P890003
- Supplement
- S058
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REVEAL PLUS INSERTABLE LOOP RECORDER MODEL 9809 SOFTWARE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1999-12-13
- Decision date
- 1999-12-27
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- The device is indicated for the programming of the adjustable parameters of the implantable recorder used in the device.
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