P920048S010

None

FDA Premarket Approval P920048 S010

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

DeviceP920048S010
Classification NameNone
Applicant
PMAP920048
SupplementS010

Supplemental Filings

Supplement NumberDateSupplement Type
P920048Original Filing
S023 2022-04-29 30-day Notice
S022 2022-03-31 30-day Notice
S021 2022-02-14 30-day Notice
S020 2021-04-09 30-day Notice
S019
S018 2020-09-08 30-day Notice
S017 2020-07-10 30-day Notice
S016
S015
S014 2018-11-20 30-day Notice
S013
S012
S011 2015-06-10 Real-time Process
S010
S009 2015-04-09 Real-time Process
S008 2014-06-24 30-day Notice
S007
S006 2008-09-29 30-day Notice
S005 2007-12-21 Normal 180 Day Track No User Fee
S004
S003 2000-09-11 Normal 180 Day Track
S002 1998-02-13 Normal 180 Day Track
S001 1996-06-26 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15420045500884 P920048 006
15420045500877 P920048 006
15420045501171 P920048 008
15420045501164 P920048 008
15420045505346 P920048 009

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