ALIZEA and CELEA pacemakers, Remote monitoring software (RMS)
FDA premarket approval P950029/S132 · decided 2023-05-17
Approval details
- PMA number
- P950029
- Supplement
- S132
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALIZEA and CELEA pacemakers, Remote monitoring software (RMS)
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2022-09-12
- Decision date
- 2023-05-17
- Days to decision
- 247 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for upgrades to the following devices and associated software packages: ALIZEA and CELEA pacemakers, Orchestra Plus and SmartTouch programmer software modules, CPR4 Telemetry head accessory, and the Remote Monitoring System.
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