Absorbable Coronary Drug-Eluting Stent

PNY · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: PNY
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: CV
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: Y
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown