MEDTRONIC CARELINK REMOTE HOME MONITOR
FDA premarket approval P890003/S195 · decided 2011-03-17
Approval details
- PMA number
- P890003
- Supplement
- S195
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC CARELINK REMOTE HOME MONITOR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2010-07-06
- Decision date
- 2011-03-17
- Days to decision
- 254 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO REDUCE THE 21-DAY SCHEDULING OF DEVICE INTERROGATION REQUIREMENT WITHIN THE DEVICE FIRMWARE, AS WELL AS LABELING MODIFICATIONS TO DISCLOSE THE EFFECTS OF THIS PROGRAMMABILITY ON THE LONGEVITY OF THE PULSE GENERATORS.
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