Severity: Warning
Message: unlink(/var/lib/php/5.6/session/ci_sessionbrafgc1oghv826bvgmd1260bqq4g3dkq): 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_sessionheduir82illd79o73va0st1p41bujl4j): 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_sessionkc9mnnf7sqd0mqcu532ep3mdji0scq1v): 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_sessiond4gk4k4l4fqvq3luq0pbnjnu7npb5f18): 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_sessioncvg6olauqmeeqlmsm7kdq4lcbe45fj7m): 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_session661s3jo7cm3la55u2mdolbu4gvilnvln): 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_session7tq1jsve58uifu2fjdfs508hc9ai1o3u): 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_sessionptuecdbtoe8krsvh68h0n7ae9p3il8na): 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_sessionn3bfct9h8kr4eh5n03eaco96t72n1vto): 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_session2pnk667ahgkts85tig6i91lv8fv8nvio): 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_session5akhnu6gfamr31g0eb5cj0li37mdj38r): 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_sessionq954h0rji1q2gg01soaegac3c121mta3): 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_session4amf5f585dq445uj1odrq5k4vqeplru5): 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_sessionf8rflsu954b36d3h2rcvafeuchi8j57b): 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_sessionfi0ckedm5rq8rakhrk7e2lvpmc3ciclm): 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_sessionsur061cnk4ec2e7rbsvdpc6mpbk6fad4): 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_session5g5oealb59jpoo8r01fn7fcvpkhkv9au): 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_session4ap59lod9lq8c2v2bmg16es5mte2rpc1): 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_sessionudmbkdraol8ul69j9qps6va0qbbhf6j9): 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_sessionfpr9i6rdidsbfrnpkendo4724i0268k9): 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_sessionk5jgp0tk2rvm33rhjd1isfahhuqvcg8q): 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.
To relocate the manufacturing facility for the bioabsorbable component
| Device | EXOSEAL Vascular Closure |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Cordis Corporation |
| Date Received | 2019-02-28 |
| Decision Date | 2019-03-26 |
| PMA | P100013 |
| Supplement | S018 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cordis Corporation 1820 Mccarthy Boulevard milpitas, CA 95035 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100013 | Original Filing | |
| S026 | 2022-10-21 | 30-day Notice |
| S025 | ||
| S024 | 2022-01-31 | 30-day Notice |
| S023 | 2021-11-17 | 30-day Notice |
| S022 | 2021-10-27 | 30-day Notice |
| S021 | 2021-09-10 | 30-day Notice |
| S020 | 2019-05-24 | 30-day Notice |
| S019 | 2019-04-05 | 30-day Notice |
| S018 | 2019-02-28 | 30-day Notice |
| S017 | 2018-07-12 | 30-day Notice |
| S016 | ||
| S015 | 2017-08-11 | Normal 180 Day Track No User Fee |
| S014 | 2017-04-11 | 135 Review Track For 30-day Notice |
| S013 | 2016-06-02 | 30-day Notice |
| S012 | 2015-07-23 | 30-day Notice |
| S011 | ||
| S010 | 2014-03-24 | 30-day Notice |
| S009 | 2013-04-09 | 30-day Notice |
| S008 | 2012-12-03 | 30-day Notice |
| S007 | 2012-11-13 | 30-day Notice |
| S006 | 2012-09-13 | 30-day Notice |
| S005 | 2012-07-16 | 30-day Notice |
| S004 | 2012-06-19 | 30-day Notice |
| S003 | 2011-12-12 | Real-time Process |
| S002 | 2011-08-30 | 30-day Notice |
| S001 | 2011-07-28 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 20705032058893 | P100013 | 010 |
| 20705032058879 | P100013 | 010 |
| 20705032058855 | P100013 | 010 |