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Devices
QuickSite, QuickSite XL
Model / Serial
All lots
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution -- Algeria, Argentina, Australia, Austria, Bahrain, Balkan, Baltic, Belarus, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Montenegro, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Paraguay, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Senegal, Serbia, Serbia Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, US, Venezuela, and Yemen.
Product Description
Cardiac Resynchronization Therapy (CRT) Leads. || Trade Name: QuickSite, QuickSite XL || Model Numbers: QuickSite and QuickSite XL: Models 1056T, model 1058T || Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead
Manufacturer
St Jude Medical CRMD
1 Event
Recall of QuickSite, QuickSite XL
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Manufacturer
St Jude Medical CRMD
Manufacturer Address
St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
Source
USFDA
Language
English
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