CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)

Heart-valve, Mechanical

FDA Premarket Approval P900060 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

• Device: CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
• Classification Name: Heart-valve, Mechanical
• Generic Name: Heart-valve, Mechanical
• Applicant: SORIN GROUP ITALIA S.R.L
• Date Received: 1993-10-15
• Decision Date: 1994-04-13
• PMA: P900060
• Supplement: S001
• Product Code: LWQ
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: SORIN GROUP ITALIA S.R.L via Crescentino, Sn saluggia, Vc 13040

Supplemental Filings

Supplement Number	Date	Supplement Type
P900060		Original Filing
S064	2022-02-07	30-day Notice
S063	2021-08-10	Special (immediate Track)
S062
S061	2020-07-09	135 Review Track For 30-day Notice
S060	2019-07-01	30-day Notice
S059	2018-07-10	30-day Notice
S058	2018-06-15	30-day Notice
S057	2018-04-30	30-day Notice
S056	2017-02-10	30-day Notice
S055
S054	2015-08-10	30-day Notice
S053	2014-01-23	30-day Notice
S052	2013-06-25	30-day Notice
S051	2012-05-23	30-day Notice
S050	2012-05-23	135 Review Track For 30-day Notice
S049	2012-03-27	135 Review Track For 30-day Notice
S048	2012-02-07	30-day Notice
S047	2011-10-31	30-day Notice
S046	2011-08-05	30-day Notice
S045	2011-06-14	30-day Notice
S044	2011-06-02	30-day Notice
S043	2011-06-02	30-day Notice
S042	2011-06-02	30-day Notice
S041	2011-02-28	Real-time Process
S040	2008-05-02	30-day Notice
S039	2007-06-19	Normal 180 Day Track No User Fee
S038	2007-03-27	30-day Notice
S037	2006-10-10	Normal 180 Day Track No User Fee
S036	2006-01-10	30-day Notice
S035	2005-12-16	30-day Notice
S034	2005-09-06	135 Review Track For 30-day Notice
S033	2005-05-26	Normal 180 Day Track No User Fee
S032	2005-05-17	Normal 180 Day Track No User Fee
S031
S030	2005-01-27	135 Review Track For 30-day Notice
S029	2004-06-14	30-day Notice
S028
S027	2003-08-22	30-day Notice
S026	2003-06-27	30-day Notice
S025	2003-05-13	Real-time Process
S024	2002-06-11	Normal 180 Day Track
S023	2002-02-26	Normal 180 Day Track
S022	2001-01-22	30-day Notice
S021	2000-08-07	30-day Notice
S020	1999-07-21	Normal 180 Day Track
S019	1999-05-14	Real-time Process
S018	1998-09-18	Real-time Process
S017	1998-06-01	30-day Notice
S016
S015
S014	1997-05-07	Normal 180 Day Track
S013	1996-02-27	Normal 180 Day Track
S012	1996-02-08	Normal 180 Day Track
S011	1995-05-17	Normal 180 Day Track
S010	1995-02-27	Normal 180 Day Track
S009	1995-01-19	Normal 180 Day Track
S008
S007	1994-12-20	Normal 180 Day Track
S006	1994-08-30	Normal 180 Day Track
S005	1994-04-23	Special (immediate Track)
S004	1994-03-22	Normal 180 Day Track
S003	1994-03-01	Normal 180 Day Track
S002	1993-12-01	Normal 180 Day Track
S001	1993-10-15	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
08022057014016	P900060	000
08022057012937	P900060	001
08022057012906	P900060	001
08022057012890	P900060	001
08022057012920	P900060	001
08022057012913	P900060	001
08022057012791	P900060	002
08022057012807	P900060	002
08022057012814	P900060	002
08022057012722	P900060	002
08022057012739	P900060	002
08022057012746	P900060	002
08022057012753	P900060	002
08022057012760	P900060	002
08022057012777	P900060	002
08022057012715	P900060	002
08022057012586	P900060	002
08022057012593	P900060	002
08022057012609	P900060	002
08022057012616	P900060	002
08022057012623	P900060	002
08022057012630	P900060	002
08022057012647	P900060	002
08022057012654	P900060	002
08022057012661	P900060	002
08022057012784	P900060	002
08022057012685	P900060	004
08022057012678	P900060	004
08022057012708	P900060	004
08022057012692	P900060	011
08022057013484	P900060	012
08022057013491	P900060	012
08022057013521	P900060	012
08022057013477	P900060	012
08022057013460	P900060	012
08022057013514	P900060	012
08022057013507	P900060	012
08022057012524	P900060	018
08022057012531	P900060	018
08022057012517	P900060	018
08022057012548	P900060	018
08022057012555	P900060	018
08022057012579	P900060	018
08022057012449	P900060	018
08022057012500	P900060	018
08022057012494	P900060	018
08022057012487	P900060	018
08022057012470	P900060	018
08022057012463	P900060	018
08022057012456	P900060	018
08022057012562	P900060	018
08022057012883	P900060	019
08022057012845	P900060	019
08022057012838	P900060	019
08022057012852	P900060	019
08022057012869	P900060	019
08022057012821	P900060	019
08022057012876	P900060	019
08022057013576	P900060	024
08022057013538	P900060	024
08022057013545	P900060	024
08022057013569	P900060	024
08022057013552	P900060	024