FDA product code PNY: Absorbable Coronary Drug-Eluting Stent
PNY is the FDA product code for absorbable coronary drug-eluting stent. It is a Class III device, reviewed by the Cardiovascular panel. Devices under PNY reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for PNY devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Absorbable Coronary Drug-Eluting Stent |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for PNY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-04-26.
| Year | Recalls |
|---|---|
| 2017 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch
- C9600 — Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch
Frequently asked questions
What is FDA product code PNY?
PNY is the FDA product code for absorbable coronary drug-eluting stent. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is PNY?
Class III. Typical premarket route: PMA.
Have PNY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-04-26.
Next steps
- Run an FDA pathway report with predicate devices for product code PNY
- Run a recall and safety report across every PNY manufacturer
- Watch product code PNY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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