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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 6 of 6 Results
PMA Number: P140009
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Product Description
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Recall
Class
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FDA Recall
Posting Date
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Recalling Firm
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St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONL... 2 12/10/2018 St. Jude Medical, Inc.
Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661,... 2 10/17/2017 St. Jude Medical, Inc.
Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infini... 2 07/07/2017 St. Jude Medical, Inc.
Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infini... 2 07/07/2017 St. Jude Medical, Inc.
Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infi... 2 07/07/2017 St. Jude Medical, Inc.
Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infini... 2 07/07/2017 St. Jude Medical, Inc.
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