Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionb7h01ekljtkn5ab3srue6amcto0nk5mo): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_session7ame2pdd7eg2c2esn6760jdp5880c362): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionsu4i79drqfhgbn2qu0jjboi8ll68g9b9): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionnqgs1n2uv1n6ig52no26gq73dng8pa7a): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionlsdfddhpe2ifrda8h67jssvtd17vlhva): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionphrnb66q1oukjvvstnlf57uci4tgsg98): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionmep0tbc0lj2lmek8ogfk03a6idh7ta6l): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessiondql3n875kbd6r98m27kbp0ejv5v2l3ho): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionla59gp4qvu93bccblfkj4cl66l2ibnh0): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessiongr6ai2ppd649qlokqm0kf20o18sehhil): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessiondb718d556a3p22307o5qbk09r3vg8h9g): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionbtltma4bea490rokssk8nohank861e7m): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessiond3riukh8adj38fk6irs8du4atmigemnv): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionpteih69s1hddrpdhtjpek4nqe8h2vqki): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_session7q3ijt765lcga4pe59p0ajpum3n0mh45): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionshrhpuv4h8s82dtfqv6jj0iv7vi0ibqk): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionkuvpq3msfu3pkq5cansc3kdm9fe3ane7): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_session2rgh87t8uo6pq4tm5iqdacdhujuirs19): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_session4162m7gp2jtvej3so98phkoaslupvuo6): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionc3v1u9fr1bipopeh879si3uu50c6qn4c): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_session1v06o712hs7ibr9q3gjge7mg7ima14av): No such file or directory
Filename: drivers/Session_files_driver.php
Line Number: 384
Backtrace:
File: /var/www/fda.report/application/controllers/Pma.php
Line: 11
Function: __construct
File: /var/www/fda.report/codeigniter.php
Line: 316
Function: require_once
File: /var/www/fda.report/pma_item.php
Line: 10
Function: include
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.
Approval for a modified test method and specification extractables testing of pebax resin material.
| Device | FLEXTOME CUTTING BALLOON |
| Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | Boston Scientific Corp. |
| Date Received | 2010-04-08 |
| Decision Date | 2011-01-07 |
| PMA | P950020 |
| Supplement | S040 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950020 | Original Filing | |
| S134 | 2023-01-10 | 30-day Notice |
| S133 | ||
| S132 | 2022-12-02 | 30-day Notice |
| S131 | 2022-11-15 | 30-day Notice |
| S130 | ||
| S129 | 2022-10-25 | 30-day Notice |
| S128 | ||
| S127 | 2022-10-11 | 30-day Notice |
| S126 | 2022-09-19 | 30-day Notice |
| S125 | 2022-09-06 | 30-day Notice |
| S124 | 2022-07-11 | 30-day Notice |
| S123 | 2022-06-17 | 30-day Notice |
| S122 | 2022-04-29 | 30-day Notice |
| S121 | ||
| S120 | 2022-03-14 | 30-day Notice |
| S119 | ||
| S118 | 2022-03-03 | 30-day Notice |
| S117 | 2022-02-11 | 30-day Notice |
| S116 | 2022-01-28 | 30-day Notice |
| S115 | 2021-11-22 | 30-day Notice |
| S114 | 2021-11-15 | 30-day Notice |
| S113 | 2021-08-24 | 30-day Notice |
| S112 | ||
| S111 | 2020-11-19 | 30-day Notice |
| S110 | 2020-11-12 | 30-day Notice |
| S109 | 2020-08-25 | 30-day Notice |
| S108 | 2020-06-09 | 30-day Notice |
| S107 | 2020-03-30 | 30-day Notice |
| S106 | ||
| S105 | 2020-02-27 | 30-day Notice |
| S104 | 2020-02-05 | 30-day Notice |
| S103 | 2020-02-05 | 30-day Notice |
| S102 | 2020-01-28 | 30-day Notice |
| S101 | 2020-01-23 | 30-day Notice |
| S100 | 2019-12-13 | 30-day Notice |
| S099 | 2019-10-10 | 30-day Notice |
| S098 | 2019-06-27 | 30-day Notice |
| S097 | ||
| S096 | 2019-03-12 | 30-day Notice |
| S095 | 2019-02-07 | 30-day Notice |
| S094 | 2019-02-01 | 30-day Notice |
| S093 | 2019-01-23 | 30-day Notice |
| S092 | 2018-11-16 | 30-day Notice |
| S091 | 2018-10-05 | 30-day Notice |
| S090 | 2018-08-17 | 30-day Notice |
| S089 | 2018-02-16 | 30-day Notice |
| S088 | 2018-01-09 | 30-day Notice |
| S087 | 2017-10-17 | 30-day Notice |
| S086 | 2017-10-16 | 30-day Notice |
| S085 | ||
| S084 | 2017-09-29 | 30-day Notice |
| S083 | 2017-08-08 | 30-day Notice |
| S082 | 2017-08-04 | 30-day Notice |
| S081 | 2017-07-20 | 30-day Notice |
| S080 | 2017-04-11 | 30-day Notice |
| S079 | 2016-11-30 | Normal 180 Day Track No User Fee |
| S078 | 2016-11-22 | 30-day Notice |
| S077 | 2016-11-17 | 30-day Notice |
| S076 | 2016-11-02 | 30-day Notice |
| S075 | 2016-09-01 | 30-day Notice |
| S074 | ||
| S073 | 2016-05-12 | 30-day Notice |
| S072 | 2016-01-29 | Normal 180 Day Track |
| S071 | 2015-01-07 | 30-day Notice |
| S070 | ||
| S069 | 2014-08-26 | 30-day Notice |
| S068 | 2014-07-31 | 30-day Notice |
| S067 | 2014-01-17 | 30-day Notice |
| S066 | 2013-11-26 | 30-day Notice |
| S065 | 2013-09-20 | 30-day Notice |
| S064 | 2013-08-29 | 30-day Notice |
| S063 | 2013-06-10 | 30-day Notice |
| S062 | ||
| S061 | 2013-03-29 | Real-time Process |
| S060 | 2013-01-14 | 30-day Notice |
| S059 | 2012-11-19 | 30-day Notice |
| S058 | 2012-11-15 | 30-day Notice |
| S057 | 2012-11-13 | 30-day Notice |
| S056 | 2012-10-17 | 30-day Notice |
| S055 | 2012-10-10 | Normal 180 Day Track |
| S054 | 2012-09-05 | 30-day Notice |
| S053 | 2012-08-16 | 30-day Notice |
| S052 | 2012-08-13 | 30-day Notice |
| S051 | 2012-06-14 | 30-day Notice |
| S050 | 2012-05-21 | 30-day Notice |
| S049 | 2012-02-29 | 30-day Notice |
| S048 | 2011-12-13 | 135 Review Track For 30-day Notice |
| S047 | 2011-11-04 | 30-day Notice |
| S046 | 2011-07-05 | 30-day Notice |
| S045 | 2011-06-21 | 30-day Notice |
| S044 | 2011-06-01 | 30-day Notice |
| S043 | ||
| S042 | 2010-12-22 | 135 Review Track For 30-day Notice |
| S041 | ||
| S040 | 2010-04-08 | 135 Review Track For 30-day Notice |
| S039 | 2010-03-12 | 30-day Notice |
| S038 | 2010-01-26 | 30-day Notice |
| S037 | 2010-01-26 | 30-day Notice |
| S036 | 2009-11-12 | Normal 180 Day Track No User Fee |
| S035 | 2009-10-01 | 135 Review Track For 30-day Notice |
| S034 | 2009-08-31 | 30-day Notice |
| S033 | ||
| S032 | 2009-03-03 | Normal 180 Day Track No User Fee |
| S031 | 2008-12-17 | 30-day Notice |
| S030 | 2008-09-05 | 30-day Notice |
| S029 | 2008-05-19 | 30-day Notice |
| S028 | ||
| S027 | 2008-05-05 | 30-day Notice |
| S026 | 2008-02-19 | 30-day Notice |
| S025 | 2007-01-24 | 30-day Notice |
| S024 | 2007-01-03 | 30-day Notice |
| S023 | 2006-12-07 | 135 Review Track For 30-day Notice |
| S022 | 2006-11-17 | 30-day Notice |
| S021 | 2006-11-07 | 30-day Notice |
| S020 | 2006-10-17 | 30-day Notice |
| S019 | 2006-09-19 | 30-day Notice |
| S018 | 2006-07-24 | 30-day Notice |
| S017 | 2006-06-02 | Special (immediate Track) |
| S016 | 2006-05-09 | 30-day Notice |
| S015 | 2005-11-22 | Normal 180 Day Track No User Fee |
| S014 | 2005-10-28 | Normal 180 Day Track No User Fee |
| S013 | 2005-09-12 | Normal 180 Day Track No User Fee |
| S012 | 2004-11-08 | Normal 180 Day Track No User Fee |
| S011 | 2004-10-19 | Normal 180 Day Track No User Fee |
| S010 | 2004-09-13 | Normal 180 Day Track |
| S009 | 2003-12-08 | 30-day Notice |
| S008 | 2003-03-21 | Real-time Process |
| S007 | 2002-11-01 | Normal 180 Day Track |
| S006 | 2002-06-28 | Normal 180 Day Track |
| S005 | 2002-05-22 | Normal 180 Day Track |
| S004 | 2001-09-17 | Normal 180 Day Track |
| S003 | 2001-08-20 | Normal 180 Day Track |
| S002 | 2001-04-06 | Normal 180 Day Track |
| S001 | 2000-10-17 | Real-time Process |