Orchestra, Orchestra Plus, and SmartTouch programming software modules
FDA premarket approval P980049/S143 · decided 2022-07-28
Approval details
- PMA number
- P980049
- Supplement
- S143
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Orchestra, Orchestra Plus, and SmartTouch programming software modules
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2022-07-20
- Decision date
- 2022-07-28
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for programmer software updates.
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