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Aortic Annuloplasty Ring

FDA product code PST · 2 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.3800
Review panel: CV
Implant: Yes
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 2017-03-21 – 2017-08-10

To correct annular dilatation and/or maintain annular geometry of the aortic valve.

PST 2017-08-10

HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm

Applicant Biostable Science & Engineering, Inc.

K number K171431

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PST 2017-03-21

HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm

Applicant Biostable Science & Engineering, Inc.

K number K163608

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