Device |
aortic annuloplasty ring |
Regulation Description |
Annuloplasty ring. |
Definition |
To correct annular dilatation and/or maintain annular geometry of the aortic valve. |
Physical State |
A three dimensional crown or waveform shaped ring. |
Technical Method |
A solid or compliant ring attached to the aortic annulus. |
Target Area |
Aortic valve. |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | PST |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Submission Type |
510(k)
|
Regulation Number |
870.3800
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
Yes
|
Third Party Review |
Not Third Party Eligible |
|
|