510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PNYClass III

Absorbable Coronary Drug-Eluting Stent

Unknown
FDA source (opens on fda.gov)

PNY is the FDA product code for Absorbable Coronary Drug-Eluting Stent, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
PNY
Device name
Absorbable Coronary Drug-Eluting Stent
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code