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Pacemaker Devices: ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, and PROPONENT

FDA premarket approval N970003/S242 · decided 2019-10-18

Approval details

PMA number
N970003
Supplement
S242
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
Pacemaker Devices: ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, and PROPONENT
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2019-07-22
Decision date
2019-10-18
Days to decision
88 days
Decision code
APPR
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Approval for modifying the Model 3300 LATITUDE Programming System software components to update the Brady device application code base, add support for 4G cellular communications, and add an integrated Heart Connect application.

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