ENRHYTHM IPG FAMILY
FDA premarket approval P980035/S136 · decided 2009-06-24
Approval details
- PMA number
- P980035
- Supplement
- S136
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENRHYTHM IPG FAMILY
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2009-03-27
- Decision date
- 2009-06-24
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR VERSION 7.1 OF THE MODEL 9987 APPLICATION SOFTWARE WHICH RESETS THE ERI VOLTAGE THRESHOLD TO COMPENSATE FOR THE POTENTIAL PREMATURE LITHIUM DEPLETION.
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510(k) clearances by this applicant
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|---|---|---|
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| Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (K260195) | Medtronic, Inc. | 2026-04-23 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| 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 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |