Stent, Coronary
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS
- PMA Number
- P970020
- Device Class
- FDA Class 3
- Product Code
- MAF
- Generic Name
- STENT, CORONARY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- October 2, 1997
- Date Received
- June 12, 1997
- Expedited Review
- N
- Docket Number
- 98M-0971
Advisory Committee Statement
Approval for the ACS Multi-Link(TM) Coronary Stent System containing ACS Multi-Link(TM) CSS, ACS RX Multi-Link(TM) Coronary Stent System containing ACS Multi-Link(TM) CSS, ACS RX Multi-Link HP(TM) CSS, ACS OTW Multi-Link HP(TM) CSS, and ACS RX Multi-Link(TM) CSS delivery platforms. The device with ACS Multi-Link(TM) CSS, ACS RX Multi-Link HP(TM) CSS and ACS OTW Multi-Link HP(TM) CSS delivery platforms is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo and restenotic native coronary artery lesions (length <20 mm) with a reference vessel diameter ranging from 3.0 mm to 3.75 mm and is intended to improve coronary luminal diameter. The device with ACS RX Multi-Link(TM) CSS delivery platform, however, is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo and restenotic native coronary artery lesions (length <22mm) with a reference vessel diameter ranging from 3.0 mm to 3.5 mm and is intended to improve coronary luminal diameter.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAF | Stent, Coronary | FDA class 3 | Unknown |