Device |
absorbable coronary drug-eluting stent |
Definition |
An absorbable scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis. |
Physical State |
Mesh tube in various lengths and diameters |
Technical Method |
Provides mechanical support to the treated artery and a drug agent to prevent restenosis of the treated artery, and then gradually dissolves and is absorbed by the body. |
Target Area |
Coronary arteries |
Review Panel |
Cardiovascular |
Product Code | PNY |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
Yes
|
Recognized Consensus Standard
|
Third Party Review |
Not Third Party Eligible |