ADVISA DR IPG
FDA premarket approval P980035/S134 · decided 2011-04-04
Approval details
- PMA number
- P980035
- Supplement
- S134
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVISA DR IPG
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2009-03-06
- Decision date
- 2011-04-04
- Days to decision
- 759 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADVISA DR A4DR01 IMPLANTABLE PULSE GENERATOR, MODEL 9995 APPLICATION SOFTWARE V7.3, CARELINK MONITOR MODEL 2490G UPGRADE, CARDIOSIGHT READER MODEL 2020A UPGRADE, AND MODEL 2491 DDMA UPGRADE.
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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