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Advantio, Ingenio, Vitalio, Formio, Essentio, Accolade, Proponent

FDA premarket approval N970003/S224 · decided 2018-03-26

Approval details

PMA number
N970003
Supplement
S224
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
Advantio, Ingenio, Vitalio, Formio, Essentio, Accolade, Proponent
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Applicant
Boston Scientific Corp
Date received
2018-01-18
Decision date
2018-03-26
Days to decision
67 days
Decision code
APPR
Product code
LWP
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Approval for a Software Maintenance Release (SMR) for the Model 3922 Pacing System Analyzer (PSA) Software Application that functions within Model 3300 LATITUDE Programming System (LPS).

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510(k) clearances by this applicant

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