P070001S003

None

FDA Premarket Approval P070001 S003

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

• Device: P070001S003
• Classification Name: None
• PMA: P070001
• Supplement: S003

Supplemental Filings

Supplement Number	Date	Supplement Type
P070001		Original Filing
S021	2021-09-21	30-day Notice
S020	2021-01-28	30-day Notice
S019
S018	2019-06-21	Normal 180 Day Track No User Fee
S017	2018-12-04	Normal 180 Day Track No User Fee
S016	2017-09-20	30-day Notice
S015	2017-06-30	30-day Notice
S014
S013	2014-04-03	135 Review Track For 30-day Notice
S012	2012-03-13	135 Review Track For 30-day Notice
S011	2011-07-19	30-day Notice
S010	2011-07-18	135 Review Track For 30-day Notice
S009	2010-08-02	Real-time Process
S008	2010-06-07	30-day Notice
S007	2010-06-02	30-day Notice
S006	2010-05-27	30-day Notice
S005	2010-05-27	135 Review Track For 30-day Notice
S004	2010-05-19	Normal 180 Day Track No User Fee
S003
S002	2008-03-12	Normal 180 Day Track No User Fee
S001	2008-01-31	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
10705034763897	P070001	000
10705034763729	P070001	000
10705034763736	P070001	000
10705034763743	P070001	000
10705034763750	P070001	000
10705034763767	P070001	000
10705034763774	P070001	000
10705034763781	P070001	000
10705034763798	P070001	000
10705034763804	P070001	000
10705034763811	P070001	000
10705034763880	P070001	000
10705034763873	P070001	000
10705034763866	P070001	000
10705034763859	P070001	000
10705034763842	P070001	000
10705034763835	P070001	000
10705034763828	P070001	000
H98109820046S04	P070001	011
H98109820045S03	P070001	011
H98109820037S04	P070001	011
H98109820036S03	P070001	011
H98109820035S02	P070001	011
H98109820027S03	P070001	011
H98109820026S02	P070001	011
H98109820025S01	P070001	011
H98109820047S05	P070001	011
H98109820055S04	P070001	011
H98109820077S08	P070001	011
H98109820076S07	P070001	011
H98109820075S06	P070001	011
H98109820067S07	P070001	011
H98109820066S06	P070001	011
H98109820065S05	P070001	011
H98109820057S06	P070001	011
H98109820056S05	P070001	011
00843193113795	P070001	019
00843193113801	P070001	019
00843193113818	P070001	019
00843193113825	P070001	019
00843193113832	P070001	019
00843193113849	P070001	019
00843193113856	P070001	019
00843193113788	P070001	019
00843193113771	P070001	019
00843193113764	P070001	019
00843193113757	P070001	019
00843193113740	P070001	019
00843193113733	P070001	019
00843193113726	P070001	019
00843193113719	P070001	019
00843193113702	P070001	019
00843193113696	P070001	019
00843193113863	P070001	019
00843193113870	P070001	019
00843193113672	P070001	019
00843193114020	P070001	019
00843193114013	P070001	019
00843193114006	P070001	019
00843193113993	P070001	019
00843193113986	P070001	019
00843193113979	P070001	019
00843193113962	P070001	019
00843193113955	P070001	019
00843193113948	P070001	019
00843193113931	P070001	019
00843193113924	P070001	019
00843193113917	P070001	019
00843193113900	P070001	019
00843193113894	P070001	019
00843193113887	P070001	019
00843193113689	P070001	019