Device |
transcatheter septal occluder |
Definition |
Approved PMA: P000039 |
Review Panel |
Cardiovascular |
Product Code | MLV |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Submission Type |
PMA
|
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? |
Yes
|
Recognized Consensus Standards
|
Third Party Review |
Not Third Party Eligible |
|
|