P160048S012

None

FDA Premarket Approval P160048 S012

This post-approval study has not been publically released by the fda. It may be a place-holder supplement number.

Pre-market Approval Supplement Details

DeviceP160048S012
Classification NameNone
Applicant
PMAP160048
SupplementS012

Supplemental Filings

Supplement NumberDateSupplement Type
P160048Original Filing
S014 2019-08-27 Normal 180 Day Track No User Fee
S013 2019-07-31 30-day Notice
S012
S011 2019-06-27 Normal 180 Day Track
S010 2019-06-24 30-day Notice
S009 2019-05-28 30-day Notice
S008 2018-12-11 Real-time Process
S007 2018-11-28 Normal 180 Day Track No User Fee
S006
S005 2018-09-11 Real-time Process
S004 2018-09-07 Real-time Process
S003 2018-08-27 Normal 180 Day Track No User Fee
S002 2018-08-07 Normal 180 Day Track
S001 2018-07-20 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00817491020819 P160048 000
00817491021458 P160048 000
00817491021908 P160048 000
00817491020819 P160048 000
00817491020826 P160048 000
00817491021328 P160048 000
00817491021304 P160048 000
00817491021311 P160048 000
00817491021335 P160048 000
00817491021441 P160048 000
00817491021434 P160048 000
00817491021427 P160048 000
00817491020826 P160048 000
00817491021328 P160048 000
00817491021304 P160048 000
00817491021311 P160048 000
00817491021335 P160048 000
00817491021397 P160048 000
00817491021403 P160048 000
00817491021410 P160048 000
00817491021397 P160048 000
00817491021403 P160048 000
00817491021335 P160048 000
00817491021397 P160048 000
00817491021403 P160048 000
00817491021410 P160048 000
00817491021427 P160048 000
00817491021434 P160048 000
00817491021441 P160048 000
00817491021458 P160048 000
00817491021908 P160048 000
00817491021311 P160048 000
00817491021304 P160048 000
00817491021410 P160048 000
00817491021427 P160048 000
00817491021434 P160048 000
00817491021441 P160048 000
00817491021458 P160048 000
00817491021908 P160048 000
00817491020819 P160048 000
00817491020826 P160048 000
00817491021328 P160048 000
00817491022516 P160048 006
00817491022523 P160048 006
00817491022370 P160048 006
00817491022387 P160048 006
00817491022363 P160048 008
00817491022356 P160048 008
00817491022349 P160048 008

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.