P160035S013

None

FDA Premarket Approval P160035 S013

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

DeviceP160035S013
Classification NameNone
Applicant
PMAP160035
SupplementS013

Supplemental Filings

Supplement NumberDateSupplement Type
P160035Original Filing
S017 2020-09-24 30-day Notice
S016
S015 2020-08-05 30-day Notice
S014 2020-04-06 30-day Notice
S013
S012 2019-10-11 30-day Notice
S011 2019-10-11 30-day Notice
S010
S009 2019-09-26 30-day Notice
S008
S007 2019-06-20 Normal 180 Day Track
S006
S005 2019-04-10 Real-time Process
S004 2018-09-28 30-day Notice
S003 2018-01-05 30-day Notice
S002 2017-07-14 30-day Notice
S001 2017-06-29 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
04260090041369 P160035 002
04260090040386 P160035 002
04260090040508 P160035 002
04260090040539 P160035 002
04260090041277 P160035 002
04260090041284 P160035 002
04260090041291 P160035 002
04260090041307 P160035 002
04260090041321 P160035 002
04260090041338 P160035 002
04260090041352 P160035 002
04260090040379 P160035 002

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