MODEL 9802 E REVEAL INSERTABLE LOOP RECORDER SOFTWARE
FDA premarket approval P890003/S052 · decided 1998-01-29
Approval details
- PMA number
- P890003
- Supplement
- S052
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 9802 E REVEAL INSERTABLE LOOP RECORDER SOFTWARE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1997-08-18
- Decision date
- 1998-01-29
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Model 9802E Reveal(TM) Insertable Loop Recorder Software for use with the Model 9790/9790C Programmers.
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