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Devices
Device Recall Guidant RENEWAL 3 and 4 CRTD
Model / Serial
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide
Product Description
Guidant CONTAK RENEWAL 3 (Models H170, H173, H175), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Guidant CONTAK RENEWAL 4 (Models H190,H195) *, Guidant CONTAK RENEWAL 4 HE (Models H197, H199)* Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. (* models are not available in the USA).
Manufacturer
Boston Scientific CRM Corp
1 Event
Recall of Device Recall Guidant RENEWAL 3 and 4 CRTD
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Manufacturer
Boston Scientific CRM Corp
Manufacturer Address
Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
Source
USFDA
Language
English
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