BETA-CATH 3.5F SYSTEM - 60 MM

Intravascular Radiation Delivery System

FDA Premarket Approval P000018 S028

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.

Pre-market Approval Supplement Details

Approval for the 60 mm beta-cath 3. 5f system. The device, as modified, is indicated to deliver beta radiation to the site of successful percutaneous coronary intervention (pci) for the treatment of in-stent restenosis in native coronary arteries with discrete lesions (treatable with a 20 mm balloon for the 30 mm and 40 mm systems and injury areas up to 40 mm for the 60 mm system) in a reference vessel diameter ranging from 2. 7 mm to 4. 0 mm.

DeviceBETA-CATH 3.5F SYSTEM - 60 MM
Classification NameIntravascular Radiation Delivery System
Generic NameIntravascular Radiation Delivery System
ApplicantBEST VASCULAR, INC
Date Received2003-01-06
Decision Date2003-06-25
PMAP000018
SupplementS028
Product CodeMOU
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address BEST VASCULAR, INC 4350 International Boulevard norcross, GA 30093

Supplemental Filings

Supplement NumberDateSupplement Type
P000018Original Filing
S050 2019-07-30 Real-time Process
S049
S048 2016-08-19 Normal 180 Day Track
S047 2016-02-26 30-day Notice
S046 2014-11-20 Normal 180 Day Track
S045 2011-06-20 135 Review Track For 30-day Notice
S044 2010-09-24 Normal 180 Day Track No User Fee
S043 2006-11-28 Normal 180 Day Track No User Fee
S042 2006-03-09 Normal 180 Day Track No User Fee
S041 2004-06-28 Normal 180 Day Track No User Fee
S040 2003-12-16 Normal 180 Day Track
S039 2003-11-05 30-day Notice
S038 2003-10-02 30-day Notice
S037 2003-09-11 30-day Notice
S036 2003-09-10 30-day Notice
S035 2003-08-21 Normal 180 Day Track
S034 2003-05-29 30-day Notice
S033 2003-05-12 30-day Notice
S032 2003-03-03 30-day Notice
S031 2003-02-14 Special (immediate Track)
S030 2003-02-07 30-day Notice
S029 2003-01-21 Normal 180 Day Track
S028 2003-01-06 Normal 180 Day Track
S027 2002-10-21 135 Review Track For 30-day Notice
S026 2002-10-18 Special (immediate Track)
S025 2002-10-15 Normal 180 Day Track
S024 2002-09-03 30-day Notice
S023 2002-07-18 30-day Notice
S022 2002-06-06 30-day Notice
S021 2002-05-01 Real-time Process
S020
S019 2001-10-02 Normal 180 Day Track
S018 2001-08-31 Normal 180 Day Track
S017 2001-08-27 30-day Notice
S016 2001-08-07 Real-time Process
S015 2001-07-31 Normal 180 Day Track
S014 2001-06-14 30-day Notice
S013 2001-04-24 Real-time Process
S012 2001-03-09 135 Review Track For 30-day Notice
S011 2001-02-21 Real-time Process
S010 2001-02-15 30-day Notice
S009 2001-02-12 Normal 180 Day Track
S008 2001-02-02 Real-time Process
S007 2001-01-18 30-day Notice
S006 2001-01-05 30-day Notice
S005 2000-12-28 Real-time Process
S004
S003 2000-12-19 Normal 180 Day Track
S002 2000-11-17 Special (immediate Track)
S001 2000-11-14 Special (immediate Track)

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