ADAPTA VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG AND ENPULSE E1 IPG
FDA premarket approval P980035/S311 · decided 2013-05-24
Approval details
- PMA number
- P980035
- Supplement
- S311
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADAPTA VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG AND ENPULSE E1 IPG
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2013-02-26
- Decision date
- 2013-05-24
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950, 24951, READER MODEL 24955, AND ACCESSORIES, WHICH SUPPORT THE DEVICES.
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510(k) clearances by this applicant
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|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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