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Contak CD, EasyTrak, Livian, Cognis, and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibril

FDA premarket approval P010012/S546 · decided 2021-10-06

Approval details

PMA number
P010012
Supplement
S546
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Contak CD, EasyTrak, Livian, Cognis, and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibril
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Applicant
Boston Scientific Corp
Date received
2021-09-30
Decision date
2021-10-06
Days to decision
6 days
Decision code
OK30
Product code
NIK
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
Add an alternate thermal transfer ribbon for improved legibility for use in the Dorado, Puerto Rico facility.

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