| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | MULTI-LINK ULTRA/ ZETA 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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| Date Received | 06/12/1997 |
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| Decision Date | 10/02/1997 |
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| Withdrawal Date | 04/15/2025 |
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| Product Code |
MAF |
| Docket Number | 98M-0971 |
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| Advisory Committee |
Cardiovascular |
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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 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. |
| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012
S014 S015 S017 S018 S019 S020 S021 S022 S023 S024 S026 S027
S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039
S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051
S052 S053 S054 S055 S056 S057 S058 S059 S061 S062 S063 S064
S065 S066 S067 S068 S069 S070 S071 S073 S074 S075 S076 S077
S078 S079 S080 S081 S082 S083 S084 S085 S086 |
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