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Dynagen & X4, Inogen & X4, Origen & X4 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

FDA premarket approval P010012/S427 · decided 2016-08-19

Approval details

PMA number
P010012
Supplement
S427
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
Dynagen & X4, Inogen & X4, Origen & X4 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Applicant
Boston Scientific Corp
Date received
2016-07-01
Decision date
2016-08-19
Days to decision
49 days
Decision code
APPR
Product code
NIK
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Approval for a change to the acceptance criteria for a molded component.

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