MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE
FDA premarket approval P890003/S056 · decided 1998-05-21
Approval details
- PMA number
- P890003
- Supplement
- S056
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1998-04-28
- Decision date
- 1998-05-21
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a hardware upgrade to the Model 9790C Programmer (from a Intel 80486 to an Intel Pentium MMX 166 MHz) and the Model 9891 PE Software.
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