Device |
replacement heart-valve |
Regulation Description |
Replacement heart valve. |
Definition |
Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87)) |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | DYE |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Submission Type |
PMA
|
Regulation Number |
870.3925
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Third Party Review |
Not Third Party Eligible |
|
|