INSYNC 8040 DEVICE, INSYNC III 8042.8044 DEVICES
FDA premarket approval P010015/S024 · decided 2006-08-31
Approval details
- PMA number
- P010015
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC 8040 DEVICE, INSYNC III 8042.8044 DEVICES
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2006-07-21
- Decision date
- 2006-08-31
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE LONGEVITY PROJECTION UPDATE SW V1.1.
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