PMA P980049S143

Device
Orchestra, Orchestra Plus, and SmartTouch programming software modules
Applicant
MicroPort CRM USA, Inc.
PMA number
P980049
Supplement
S143
Product code
MRM
Decision date
2022-07-28
Generic name
DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement
Approval for programmer software updates.

Current openFDA PMA Record#

Device
Orchestra, Orchestra Plus, and SmartTouch programming software modules
Applicant
MicroPort CRM USA, Inc.
PMA number
P980049
Supplement
S143
Product code
MRM
Generic name
DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date
2022-07-28
Decision code
APPR
Date received
2022-07-20
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for programmer software updates.