Import Alert 74-02
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 74-02
Published Date: 04/06/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Symbion's Jarvik Total Artificial Heart And Symbion's Acute Ventricular Assist Device"
Reason for Alert:
To prevent importation of medical devices for commercial distribution or investigational use that do not have premarket approval and for which no exemption for investigational use is in effect.
Due to safety consideration and noncompliance with the Investigational Device Exemption (IDE) Regulations (21 CFR Part 812) CDRH withdrew approval for the IDE's permitting clinical research of the two medical devices.
Due to safety consideration and noncompliance with the Investigational Device Exemption (IDE) Regulations (21 CFR Part 812) CDRH withdrew approval for the IDE's permitting clinical research of the two medical devices.
Guidance:
Districts may detain, without physical examination, Symbion's Jarvik Total Artificial Heart and Symbion's Acute Ventricular Assist Device from any foreign source unless all of the following conditions are met:
1 The devices are used, and clearly labeled, for testing
(research) purposes only.
2 The devices are not intended for commercial distribution
or investigational use.
3 The devices are consigned to Symbion, Inc. Locations are
as follows:
Symbion, Inc. Symbion, Inc.
825 North 300 West 7855 South Parkway, Suite
211
Salt Lake City, Utah 84103 Tempe, Arizona 85284
1 The devices are used, and clearly labeled, for testing
(research) purposes only.
2 The devices are not intended for commercial distribution
or investigational use.
3 The devices are consigned to Symbion, Inc. Locations are
as follows:
Symbion, Inc. Symbion, Inc.
825 North 300 West 7855 South Parkway, Suite
211
Salt Lake City, Utah 84103 Tempe, Arizona 85284
Product Description:
Symbion's Jarvik Total Artificial Heart and Symbion's Acute Ventricular Assist Device
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be a Class III device, for which no approval under Section 515 is in effect and no exemption for investigational use is in effect. [Adulteration Section 501(f)(1)(B).]"
OASIS charge code - NO PMA
OASIS charge code - NO PMA
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