NOVOSTE BETA-CATH SYSTEM

Intravascular Radiation Delivery System

FDA Premarket Approval P000018 S016

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 revised post-approval study protocol for the 30 mm and 40 mm bet systems. The revised post-approval study is intended to verify that the corrective actions, intended to help minimize the incidence of device failures and malfunctions seen during the premarket clinical investigations, are successful in reducing the device failure and malfunction rate.

DeviceNOVOSTE BETA-CATH SYSTEM
Classification NameIntravascular Radiation Delivery System
Generic NameIntravascular Radiation Delivery System
ApplicantBEST VASCULAR, INC
Date Received2001-08-07
Decision Date2002-01-30
PMAP000018
SupplementS016
Product CodeMOU
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonPostapproval Study Protocol - Ode/oir
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)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.