MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 7218
FDA premarket approval P890003/S069 · decided 2002-06-12
Approval details
- PMA number
- P890003
- Supplement
- S069
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 9896 SOFTWARE FOR THE JEWEL MODEL 7218
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2002-05-13
- Decision date
- 2002-06-12
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC MODEL 9896 SOFTWARE FOR USE WITH THE MEDTRONIC MODEL 2090 PROGRAMMER SERIES FOR USE IN PROGRAMMING THE JEWEL MODEL 7218.
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