P010053S002

None

FDA Premarket Approval P010053 S002

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

DeviceP010053S002
Classification NameNone
Applicant
PMAP010053
SupplementS002

Supplemental Filings

Supplement NumberDateSupplement Type
P010053Original Filing
S016 2022-09-15 30-day Notice
S015
S014 2022-02-28 30-day Notice
S013 2020-12-22 Real-time Process
S012 2020-08-12 30-day Notice
S011 2019-11-25 30-day Notice
S010 2011-12-19 135 Review Track For 30-day Notice
S009 2011-08-16 30-day Notice
S008 2011-08-08 30-day Notice
S007 2011-02-18 Real-time Process
S006 2009-11-02 Normal 180 Day Track No User Fee
S005
S004 2008-11-10 Normal 180 Day Track No User Fee
S003 2005-08-17 Special (immediate Track)
S002
S001 2002-11-20 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00630414977737 P010053 001
00630414977720 P010053 001
00630414960975 P010053 001

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