VARIOUS FAMILIES OF PACEMAKERS, REAL PLUS & BOSS REVEAL PLUS PREVA FAMILY, VITATRON VISA, VITATRON LEGACY FAMILY, THERA
FDA premarket approval P890003/S103 · decided 2006-05-08
Approval details
- PMA number
- P890003
- Supplement
- S103
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VARIOUS FAMILIES OF PACEMAKERS, REAL PLUS & BOSS REVEAL PLUS PREVA FAMILY, VITATRON VISA, VITATRON LEGACY FAMILY, THERA
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2006-04-10
- Decision date
- 2006-05-08
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADDITION OF THE SUPPORT FOR THE INSYNC III MARQUIS TO THE 2490G CARELINK MONITOR AND THE 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) SOFTWARE, AND THE UPDATES TO THE FIRMWARE USED IN THE 2490G CARELINK MONITOR AND UPDATES TO THE 2491 DDMA SOFTWARE.
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