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COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT

FDA premarket approval P010012/S539 · decided 2021-09-17

Approval details

PMA number
P010012
Supplement
S539
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Applicant
Boston Scientific Corp
Date received
2021-06-21
Decision date
2021-09-17
Days to decision
88 days
Decision code
APPR
Product code
NIK
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Approval for the software modifications to the LATITUDE NXT Remote Patient Management System.

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510(k) clearances by this applicant

RecordFirmDate
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WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21