Orchestra, Orchestra Plus, and Smart Touch programmers
FDA premarket approval P980049/S142 · decided 2021-06-25
Approval details
- PMA number
- P980049
- Supplement
- S142
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Orchestra, Orchestra Plus, and Smart Touch programmers
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2021-01-08
- Decision date
- 2021-06-25
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for programmer and remote monitoring software updates to support Alizea and Celea pacemakers.
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