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Devices
Myopore sutureless Myocardial Pacing Lead
Model / Serial
Serial Numbers: 148399, 148400, 148401, 148402, 148403, 148404, 148405, 148406, 148407, 148408, 148409, 148410, 148411, 148412, 148413, 148414, 148415, 148416, 148417, 148418, 148419, 148420, 148421, 148422, 148423, 148424, 148427, 148430, 148431, 148433, 148434, 148435, 148436, 148437, 148438.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
CA and MN
Product Description
Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner package have been sterilized by ethylene-oxide gas. Manufactured by: Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA.
Manufacturer
Greatbatch Medical
1 Event
Recall of Myopore sutureless Myocardial Pacing Lead
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Manufacturer
Greatbatch Medical
Manufacturer Address
Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis MN 55441
Manufacturer Parent Company (2017)
Integer Holdings Corporation
Source
USFDA
Language
English
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