ADVISA DR,ADVISA DR MRI
FDA premarket approval P980035/S358 · decided 2014-07-09
Approval details
- PMA number
- P980035
- Supplement
- S358
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVISA DR,ADVISA DR MRI
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2013-12-18
- Decision date
- 2014-07-09
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC VIVA CRT-P MODEL C6TR01 IMPLANTABLEPACEMAKER WITH CARDIAC RESYNCHRONIZATION; PROGRAMMER SOFTWARE APPLICATION MODEL 9995 V8.3; AND UPDATES TO THE MEDTRONIC CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL2020A AND CARELINK EXPRESS MODEL 2020B FIRMWARE, AND TO THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA).
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510(k) clearances by this applicant
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