MEDTRONIC RELIA IMPLANTABLE PULSE GENERATOR AND MODEL SW010APPLICATION SOFTWARE
FDA premarket approval P980035/S097 · decided 2008-11-26
Approval details
- PMA number
- P980035
- Supplement
- S097
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC RELIA IMPLANTABLE PULSE GENERATOR AND MODEL SW010APPLICATION SOFTWARE
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2008-06-02
- Decision date
- 2008-11-26
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC RELIA SERIES OF PULSE GENERATORS WHICH ARE RATE RESPONSIVE, MULTI-PROGRAMMABLE, SINGLE AND DUAL CHAMBER DEVICES (MODELS REDR01, RED01, REVDD01, RESR01, RES01) AND THE ASSOCIATED SW010 APPLICATIONS SOFTWARE (VERSION 1.0).
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |