| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | ACS AND ACS RX MULTI-LINK CORONARY STENT SYSTEMS |
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| Generic Name | STENT, CORONARY |
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| Applicant | Abbott Vascular, Inc.
26531 Ynez Rd.
Temecula, CA 92591 |
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| PMA Number | P970020 |
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| Supplement Number | S005 |
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| Date Received | 08/17/1998 |
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| Decision Date | 02/18/1999 |
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| Withdrawal Date | 04/15/2025 |
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| Product Code |
MAF |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval to add the indication for abrupt or threatened abrupt closure to the product labeling for the ACS Multi-Link(TM) (OTW, RX HP(TM), and OTW HP(TM)), ACS Multi-Link RX, ACS Multi-Link (RX and OTW) Duet(TM) Coronary Stent Systems (CSS); and approval for additional stent sizes for the ACS Multi-Link RX (stents with 2.5 mm diameter or 35 mm length) and ACS Multi-Link (RX and OTW) Duet(TM) (stents with 2.5 mm diameter or 38 mm length)CSS. These devices are indicated for use as follows: The ACS Multi-Link(TM) OTW, RX HP(TM), and OTW HP(TM) CSS is indicated for use in patients with symptomatic ischemic heart disease: due to discrete de novo native coronary artery lesions (length < 20 mm) with a reference vessel diameter ranging from 3.0 mm to 3.75 mm; due to discrete restenotic native coronary artery lesions (length < 20mm) with a reference vessel deameter ranging from 3.0 mm to 3.75mm; presenting with abrupt or threatened abrupt closure of native coronary arteries (lesion length < 20mm) with a reference vessel diameter ranging from 3.0mm to 3.75mm); and is intended to improve coronary luminal diameter. Long term outcome (beyond six months) for this permanent implant is unknown at present. The ACS Multi-Link(TM) RX CSS is indicated for use in patients with symptomatic ischemic heart disease: due to discrete de novo native coronary artery lesions (length < 22mm) with a reference vessel diameter raning from 3.0mm to 3.5mm; due to discrete restenotic native coronary artery lesions (length <22mm) with a reference vessel diameter raning from 3.0mm to 3.5mm; presenting with abrupt or threatened abrupt closure of native coronary arteries (lesion length <32mm) with a reference vessel diameter raning from 2.5mm to 3.5mm; and is intended to improve coronary luminal diameter. Long term outcome (beyond six months) for this permanent implant is unknown at present. Note: The 2.5mm diamter and 35mm length stents are indicated solely for use in patients with abrupt or threatened |
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