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ADVANTIO, INGENIO, VITALO, FORMIO, ESSENTO, ACCOLADE, PROPONENT Families of Pacemaker Devices

FDA premarket approval N970003/S207 · decided 2017-08-07

Approval details

PMA number
N970003
Supplement
S207
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ADVANTIO, INGENIO, VITALO, FORMIO, ESSENTO, ACCOLADE, PROPONENT Families of Pacemaker Devices
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2017-05-22
Decision date
2017-08-07
Days to decision
77 days
Decision code
APPR
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Approval for the LATITUDE NXT Release 5.0.1 Communicator software to add support for an alternative cellular adapter.

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