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Important Medical Device Advisory
Premature Battery Depletion with
Implantable Cardioverter Defibrillator
Affected U.S. Models can be found in the Appendix to this letter11 October 2016
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We
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Step 1: Start by gathering all the necessary information related to the medical device.
02
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08
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09
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10
Step 10: Follow any additional instructions or guidelines provided by the regulatory body.
Who needs important medical device advisory?
01
Manufacturers of medical devices
02
Distributors and importers of medical devices
03
Clinical laboratories
04
Healthcare facilities
05
Healthcare professionals
06
Regulatory bodies and authorities
07
Public health agencies
08
Research institutions and universities
09
Medical device users
10
Patients and caregivers
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What is important medical device advisory?
Important medical device advisory is a notification issued by regulatory authorities regarding the safety and effectiveness of a medical device.
Who is required to file important medical device advisory?
Manufacturers, importers, and distributors of medical devices are required to file important medical device advisory.
How to fill out important medical device advisory?
Important medical device advisory can be filled out online through the regulatory authority's designated portal.
What is the purpose of important medical device advisory?
The purpose of important medical device advisory is to inform healthcare professionals and patients about potential risks associated with a medical device.
What information must be reported on important medical device advisory?
The information reported on important medical device advisory includes details about the device, the issue, any adverse events, and recommended actions.
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