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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACS AND ACS RX MULTI-LINK CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Nameintravascular coronary stent
ApplicantGUIDANT CORP.
PMA NumberP970020
Supplement NumberS005
Date Received08/17/1998
Decision Date02/18/1999
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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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