A PHP Error was encountered

Severity: Notice

Message: Undefined index: pmaNumber

Filename: fda.report/pmn_item.php

Line Number: 21

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 21
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 25

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 25
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 25

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 25
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 26

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 26
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 26

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 26
Function: _error_handler

510(k) FDA Premarket Notification P880087

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 33

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 33
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: classificationName

Filename: fda.report/pmn_item.php

Line Number: 34

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 34
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 35

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 35
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 54

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 54
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 55

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 55
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicant

Filename: fda.report/pmn_item.php

Line Number: 66

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 66
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 66

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 66
Function: _error_handler

The following data is part of a premarket notification filed by with the FDA for .

Pre-market Notification Details

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceId

Filename: fda.report/pmn_item.php

Line Number: 78

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 78
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: 501kNumber

Filename: fda.report/pmn_item.php

Line Number: 79

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 79
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 80

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 80
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: classificationName

Filename: fda.report/pmn_item.php

Line Number: 81

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 81
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicantFull

Filename: fda.report/pmn_item.php

Line Number: 82

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 82
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicantContact

Filename: fda.report/pmn_item.php

Line Number: 83

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 83
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: applicantContact

Filename: fda.report/pmn_item.php

Line Number: 83

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 83
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondent

Filename: fda.report/pmn_item.php

Line Number: 84

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 84
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondentContact

Filename: fda.report/pmn_item.php

Line Number: 84

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 84
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondentContact

Filename: fda.report/pmn_item.php

Line Number: 85

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 85
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: correspondent

Filename: fda.report/pmn_item.php

Line Number: 85

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 85
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: classificationPC

Filename: fda.report/pmn_item.php

Line Number: 87

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 87
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: subsequentPC

Filename: fda.report/pmn_item.php

Line Number: 90

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 90
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: regulationNumber

Filename: fda.report/pmn_item.php

Line Number: 95

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 95
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: decision

Filename: fda.report/pmn_item.php

Line Number: 99

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 99
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: regulationMS

Filename: fda.report/pmn_item.php

Line Number: 100

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 100
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: 501kReviewPanel

Filename: fda.report/pmn_item.php

Line Number: 103

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 103
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: fdaReview

Filename: fda.report/pmn_item.php

Line Number: 106

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 106
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: fdaReview

Filename: fda.report/pmn_item.php

Line Number: 107

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 107
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: type

Filename: fda.report/pmn_item.php

Line Number: 109

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 109
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: thirdPartyReviewed

Filename: fda.report/pmn_item.php

Line Number: 110

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 110
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: combinationProduct

Filename: fda.report/pmn_item.php

Line Number: 111

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 111
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: dateReceived

Filename: fda.report/pmn_item.php

Line Number: 112

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 112
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: decisionDate

Filename: fda.report/pmn_item.php

Line Number: 113

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 113
Function: _error_handler

A PHP Error was encountered

Severity: Notice

Message: Undefined index: summary

Filename: fda.report/pmn_item.php

Line Number: 114

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 114
Function: _error_handler

Correspondent

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380652535823 P880087 002
00380652535632 P880087 002
00380652535625 P880087 002
00380652535618 P880087 002
00380652535601 P880087 002
00380652535595 P880087 002
00380650701473 P880087 002
00380650701466 P880087 002
00380650701442 P880087 002
00380650701435 P880087 002
00380650701428 P880087 002
00380650701411 P880087 002
00380650701404 P880087 002
00380650701398 P880087 002
00380650701381 P880087 002
00380650701374 P880087 002
00380650701367 P880087 002
00380652535649 P880087 002
00380652535656 P880087 002
00380652535816 P880087 002
00380652535809 P880087 002
00380652535793 P880087 002
00380652535786 P880087 002
00380652535779 P880087 002
00380652535762 P880087 002
00380652535755 P880087 002
00380652535748 P880087 002
00380652535731 P880087 002
00380652535724 P880087 002
00380652535717 P880087 002
00380652535700 P880087 002
00380652535694 P880087 002
00380652535687 P880087 002
00380652535670 P880087 002
00380652535663 P880087 002
00380650701350 P880087 002
00380650701343 P880087 002
00380650701336 P880087 002
00380650701145 P880087 002
00380650701138 P880087 002
00380650701121 P880087 002
00380650701114 P880087 002
00380650701107 P880087 002
00380650701091 P880087 002
00380650701084 P880087 002
00380650701077 P880087 002
00380650701060 P880087 002
00380650701053 P880087 002
00380650701046 P880087 002
00380650141224 P880087 002
00380650141217 P880087 002
00380650141200 P880087 002
00380650141194 P880087 002
00380650141187 P880087 002
00380650701152 P880087 002
00380650701169 P880087 002
00380650701329 P880087 002
00380650701312 P880087 002
00380650701305 P880087 002
00380650701299 P880087 002
00380650701282 P880087 002
00380650701275 P880087 002
00380650701268 P880087 002
00380650701251 P880087 002
00380650701244 P880087 002
00380650701237 P880087 002
00380650701220 P880087 002
00380650701213 P880087 002
00380650701206 P880087 002
00380650701190 P880087 002
00380650701183 P880087 002
00380650701176 P880087 002
00380650141170 P880087 002
00380652535830 P880087 002
00380652536561 P880087 002
00380652536370 P880087 002
00380652536363 P880087 002
00380652536356 P880087 002
00380652536349 P880087 002
00380652536332 P880087 002
00380652536325 P880087 002
00380652536318 P880087 002
00380652536301 P880087 002
00380652536295 P880087 002
00380652536288 P880087 002
00380652536271 P880087 002
00380652536264 P880087 002
00380652536257 P880087 002
00380652536240 P880087 002
00380652536233 P880087 002
00380652536226 P880087 002
00380652536387 P880087 002
00380652536394 P880087 002
00380652536554 P880087 002
00380652536547 P880087 002
00380652536530 P880087 002
00380652536523 P880087 002
00380652536516 P880087 002
00380652536509 P880087 002
00380652536493 P880087 002
00380652536486 P880087 002
00380652536479 P880087 002
00380652536462 P880087 002
00380652536455 P880087 002
00380652536448 P880087 002
00380652536431 P880087 002
00380652536424 P880087 002
00380652536417 P880087 002
00380652536400 P880087 002
00380652536219 P880087 002
00380652536202 P880087 002
00380652536196 P880087 002
00380652536004 P880087 002
00380652535991 P880087 002
00380652535984 P880087 002
00380652535977 P880087 002
00380652535960 P880087 002
00380652535953 P880087 002
00380652535946 P880087 002
00380652535939 P880087 002
00380652535922 P880087 002
00380652535915 P880087 002
00380652535908 P880087 002
00380652535892 P880087 002
00380652535885 P880087 002
00380652535878 P880087 002
00380652535861 P880087 002
00380652535854 P880087 002
00380652536011 P880087 002
00380652536028 P880087 002
00380652536189 P880087 002
00380652536172 P880087 002
00380652536165 P880087 002
00380652536158 P880087 002
00380652536141 P880087 002
00380652536134 P880087 002
00380652536127 P880087 002
00380652536110 P880087 002
00380652536103 P880087 002
00380652536097 P880087 002
00380652536080 P880087 002
00380652536073 P880087 002
00380652536066 P880087 002
00380652536059 P880087 002
00380652536042 P880087 002
00380652536035 P880087 002
00380652535847 P880087 002

A PHP Error was encountered

Severity: Notice

Message: Undefined index: deviceName

Filename: fda.report/pmn_item.php

Line Number: 156

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 156
Function: _error_handler

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