No Love for Amplatzer From FDA Reviewers | 合法醫療器材資訊網

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AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm ... Read More

Z-0053-2007 - AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The AMPLATZER PFO Occluder is a​ ... Read More

The Amplatzer ASD closure device is passed through a septal defect and is ... (​ASDs), but are frequently used off-label to treat patent foramen ovales (PFO). Read More

2016年10月31日 — AGA Medical, which developed the PFO Occluder, voluntarily recalled the device in 2006 after the FDA concluded the target population for the ... Read More

Recall of AMPLATZER PFO OCCLUDER ... According to Health Canada (via FOI)​, this recall involved a device in Canada that was produced by AGA MEDICAL ... Read More

由 HFAN EXPERT 著作 — Amplatzer PFO Occluder is the industry's leading patent foramen ovale (PFO) closure device with over 100000 devices implanted worldwide. See clinical data. Read More

2016年5月23日 — The Amplatzer patent foramen ovale (PFO) occluder faces an FDA advisory committee tomorrow, but the agency's review highlighted problems ... Read More