# Biointegral Surgical · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 1 200 Britannia Rd E , Mississauga, On CANADA _(verified: appears in the quote below)_
- **Date published:** 11/13/2012 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **Product:** Porcine Pericardial Patch | Injectable Bio-Pulmonic Pulmonic Valve | BioMitral Bio-Aortic Replacement Aortic and Mitral Valve | MitroFix Mitral Valve Restoration _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class III | Class III _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).