Biointegral Surgical · 89-08 · CANADA

For Biointegral Surgical · 89-08 · CANADA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CANADA; product is Porcine Pericardial Patch | Injectable Bio-Pulmonic Pulmonic Valve | BioMitral Bio-Aortic Replacement Aortic and Mitral Valve | MitroFix Mitral Valve Restoration; product code is 74 D - - XZ Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene | 74 L - - WR Tissue, Heart-Valve | 74 L - - WR Tissue, Heart-Valve | 74 - - - -- Cardiovascular; date published is 11/13/2012; address is 1 200 Britannia Rd E , Mississauga, On CANADA, verified against its source on 2026-09-16.

Firm: Biointegral Surgical verified
Import alert: 89-08
Import alert name: "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
Country: CANADA verified
Address: 1 200 Britannia Rd E , Mississauga, On CANADA verified
Date published: 11/13/2012 verified
Product code: 74 D - - XZ Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene | 74 L - - WR Tissue, Heart-Valve | 74 L - - WR Tissue, Heart-Valve | 74 - - - -- Cardiovascular each item verified
Product: Porcine Pericardial Patch | Injectable Bio-Pulmonic Pulmonic Valve | BioMitral Bio-Aortic Replacement Aortic and Mitral Valve | MitroFix Mitral Valve Restoration each item verified
FDA notes: Class II | Class III | Class III each item verified

Sourceaccessdata.fda.gov

Verified2026-09-16

Review by2026-11-15

DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Biointegral Surgical Date Published : 11/13/2012 1 200 Britannia Rd E , Mississauga, On CANADA 74 D - - XZ Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene Date Published: 11/13/2012 Desc: Porcine Pericardial Patch Notes: Class II 74 L - - WR Tissue, Heart-Valve Date Published: 11/13/2012 Desc: Injectable Bio-Pulmonic Pulmonic Valve Notes: Class III 74 L - - WR Tissue, Heart-Valve Date Published: 11/13/2012 Desc: BioMitral Bio-Aortic Replacement Aortic and Mitral Valve Notes: Class III 74 - - - -- Cardiovascular Date Published: 11/13/2012 Desc: MitroFix Mitral Valve Restoration

— accessdata.fda.gov, retrieved 2026-09-15

Source

accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.

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Biointegral Surgical · 89-08 · CANADA

What the source says

Source

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