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COGNIS, PROGENY CRT-D AND NG CRT-D MODELS

FDA premarket approval P010012/S355 · decided 2014-07-16

Approval details

PMA number
P010012
Supplement
S355
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
COGNIS, PROGENY CRT-D AND NG CRT-D MODELS
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Applicant
Boston Scientific Corp
Date received
2014-05-09
Decision date
2014-07-16
Days to decision
68 days
Decision code
APPR
Product code
NIK
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL FOR MODEL 2868 APPLICATION SOFTWARE VERSION 3.04 AND FIRMWARE VERSION A_V1.04 WITH PATCH V4.01 AND FIRMWARE VERSION B_V1.02 WITH PATCH V3.01 FOR THE DEVICES.

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