INSYNC 8040 DEVICES
FDA premarket approval P010015/S014 · decided 2004-09-15
Approval details
- PMA number
- P010015
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC 8040 DEVICES
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2004-08-23
- Decision date
- 2004-09-15
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO UPDATE THE LONGEVITY PROJECTIONS FOR THE MODEL 9879 SOFTWARE FOR THERA/THERA-I/PRODIGY DEVICES, MODEL 9849 SOFTWARE FOR THE LEGACY II/VISA DEVICES, MODEL 9847 SOFTWARE FOR 7968-I THERA DR DEVICE AND MODEL 9980 SOFTWARE FOR THE INSYNC 8040 DEVICE.
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510(k) clearances by this applicant
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