CareLink SmartSync Device Manager - Pacing System Analyzer
FDA 510(k) clearance K163008 · decided 2017-02-28
Clearance details
- K-number
- K163008
- Device name
- CareLink SmartSync Device Manager - Pacing System Analyzer
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-28
- Decision date
- 2017-02-28
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- DTA
- Device class
- 2
- Regulation number
- 870.3720
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mounds View, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| SynchroMed Infusion Systems (P860004/S453) | Medtronic, Inc. | 2025-12-19 |
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| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |