MODEL 9855 SOFTWARE SYSTEM
FDA premarket approval P890003/S009 · decided 1991-11-25
Approval details
- PMA number
- P890003
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 9855 SOFTWARE SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1991-08-02
- Decision date
- 1991-11-25
- Days to decision
- 115 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
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