Biointegral Surgical · 89-08 · CANADA
For Biointegral Surgical, import alert is 89-08; country is CANADA; 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)"; product is MitroFix Mitral Valve Restoration | Porcine Pericardial Patch | Injectable Bio-Pulmonic Pulmonic Valve | BioMitral Bio-Aortic Replacement Aortic and Mitral Valve; product code is 74 - - - -- Cardiovascular | 74 D - - XZ Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene | 74 L - - WR Tissue, Heart-Valve | 74 L - - WR Tissue, Heart-Valve; date published is 11/13/2012; address is 1 200 Britannia Rd E , Mississauga, On CANADA, verified against its source on 2026-09-30.
- 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 - - - -- Cardiovascular | 74 D - - XZ Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene | 74 L - - WR Tissue, Heart-Valve | 74 L - - WR Tissue, Heart-Valve each item verified
- Product
- MitroFix Mitral Valve Restoration | Porcine Pericardial Patch | Injectable Bio-Pulmonic Pulmonic Valve | BioMitral Bio-Aortic Replacement Aortic and Mitral Valve each item verified
- FDA notes
- Class II | Class III | Class III each item verified
What the source says
Biointegral Surgical Date Published : 11/13/2012 1 200 Britannia Rd E , Mississauga, On CANADA
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
74 - - - -- Cardiovascular Date Published: 11/13/2012 Desc: MitroFix Mitral Valve Restoration 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
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html