Magic Wallstent Self-Expanding Coronary Stent
by Boston Scientific Scimed, Inc. PMA
Withdrawn
PMA P980009
Overview
The Magic Wallstent Self-Expanding Coronary Stent is a self-expanding coronary stent designed to improve coronary luminal diameter. It is classified as a coronary stent and is intended for use in patients with symptomatic ischemic disease due to de novo lesions in native coronary arteries, with a reference vessel diameter of 3.0 to 5.5 mm and lesion length under 35 mm. It is also indicated for treating abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters within the same range.
This device is supplied as a single-use, sterile endoprosthesis and is regulated under an FDA Premarket Approval (PMA) with PMA number P980009. It is intended for use in percutaneous coronary interventions (PCI) and is available in various sizes and configurations as referenced by its product codes. The stent is designed for deployment via catheter-based techniques in controlled clinical settings, adhering to strict regulatory and sterility standards.
Regulatory status
Withdrawn since 29 Sep 1998. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP980009 | Date29 Sep 1998 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Magic Wallstent(R) Self-Expanding Coronary Stent
- Trade Name
- Magic Wallstent Endoprothesis
- Generic Name
- STENT, CORONARY
- PMA Number
- FDA Product Code
- MAF
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APWD Approval withdrawn