PMA P980049S142
- Device
- Orchestra, Orchestra Plus, and Smart Touch programmers
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S142
- Product code
- MRM
- Decision date
- 2021-06-25
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Approval for programmer and remote monitoring software updates to support Alizea and Celea pacemakers.
Current openFDA PMA Record#
- Device
- Orchestra, Orchestra Plus, and Smart Touch programmers
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S142
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2021-06-25
- Decision code
- APPR
- Date received
- 2021-01-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for programmer and remote monitoring software updates to support Alizea and Celea pacemakers.