THINPREP 2000 SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Premarket Approval P950039 S014

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

Approval for a manufacturing site located at cytyc corporation, marlborough, massachusetts.

• Device: THINPREP 2000 SYSTEM
• Classification Name: Processor, Cervical Cytology Slide, Automated
• Generic Name: Processor, Cervical Cytology Slide, Automated
• Applicant: HOLOGIC, INC.
• Date Received: 2005-02-14
• Decision Date: 2005-03-18
• PMA: P950039
• Supplement: S014
• Product Code: MKQ
• Advisory Committee: Pathology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: HOLOGIC, INC. 250 Campus Drive marlborough, MA 01752

Supplemental Filings

Supplement Number	Date	Supplement Type
P950039		Original Filing
S040	2020-09-30	Normal 180 Day Track
S039	2020-04-15	135 Review Track For 30-day Notice
S038	2019-06-05	Real-time Process
S037	2018-11-23	30-day Notice
S036	2017-07-31	Panel Track
S035	2016-10-05	Special (immediate Track)
S034	2015-10-01	Real-time Process
S033
S032	2014-11-21	30-day Notice
S031	2014-09-30	Real-time Process
S030	2014-08-29	Special (immediate Track)
S029	2014-08-15	30-day Notice
S028	2014-04-02	30-day Notice
S027	2013-12-31	30-day Notice
S026	2013-06-27	Normal 180 Day Track
S025
S024	2012-02-14	Real-time Process
S023
S022
S021	2010-02-25	30-day Notice
S020	2009-10-01	30-day Notice
S019
S018	2007-06-11	Normal 180 Day Track No User Fee
S017	2006-09-05	Special (immediate Track)
S016	2005-07-22	Normal 180 Day Track
S015	2005-04-01	Normal 180 Day Track
S014	2005-02-14	Normal 180 Day Track No User Fee
S013	2004-10-18	Normal 180 Day Track No User Fee
S012	2004-08-10	Normal 180 Day Track
S011	2003-10-31	Normal 180 Day Track No User Fee
S010	2003-02-19	Special (immediate Track)
S009	2003-01-21	Special (immediate Track)
S008	2001-12-10	Normal 180 Day Track
S007	2001-02-23	Normal 180 Day Track
S006	1999-10-27	Normal 180 Day Track
S005	1996-10-15
S004	1996-10-02	Normal 180 Day Track
S003	1996-09-27	Normal 180 Day Track
S002	1996-07-30	Normal 180 Day Track
S001	1996-06-07	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
15420045501072	P950039	000
25420045501093	P950039	000
15420045513952	P950039	000
15420045513945	P950039	000
15420045514652	P950039	000
15420045514683	P950039	000
15420045508040	P950039	000
25420045501109	P950039	000
15420045514652	P950039	028
25420045501109	P950039	028
15420045514683	P950039	028
15420045500839	P950039	028
25420045501093	P950039	028
25420045501086	P950039	028
15420045504011	P950039	028
15420045504004	P950039	028
15420045501072	P950039	028
15420045500846	P950039	028
15420045513945	P950039	032
15420045513952	P950039	032
15420045507005	P950039	032
15420045504158	P950039	032
15420045508040	P950039	036
15420045514157	P950039	040
15420045514140	P950039	040
15420045514133	P950039	040
15420045513860	P950039	040