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Pacemaker Devices - ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported

FDA premarket approval N970003/S247 · decided 2020-04-01

Approval details

PMA number
N970003
Supplement
S247
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
Pacemaker Devices - ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2020-01-03
Decision date
2020-04-01
Days to decision
89 days
Decision code
APPR
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Approval for software changes included in LATITUDE NXT Patient Management System, Release 6.1.5 and associated changes in Server and Communicator software updates.

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