PROGEL PLEURAL AIR LEAK SEALANT

Sealant, Polymerizing

FDA Premarket Approval P010047

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for progel pleural air leak sealant. The device is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (>=2 mm) incurred during open resection of lung parenchyma.

• Device: PROGEL PLEURAL AIR LEAK SEALANT
• Classification Name: Sealant, Polymerizing
• Generic Name: Sealant, Polymerizing
• Applicant: NEOMEND, INC.
• Date Received: 2001-08-23
• Decision Date: 2010-01-14
• Notice Date: 2010-01-27
• PMA: P010047
• Supplement: S
• Product Code: NBE
• Docket Number: 10M-0068
• Advisory Committee: Anesthesiology
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: NEOMEND, INC. 60 Technology Dr. irvine, CA 92618
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P010047		Original Filing
S067	2022-08-08	30-day Notice
S066	2021-08-16	30-day Notice
S065
S064	2021-01-14	30-day Notice
S063
S062	2020-05-01	135 Review Track For 30-day Notice
S061	2019-01-23	30-day Notice
S060	2018-08-17	30-day Notice
S059	2018-06-27	30-day Notice
S058	2018-05-14	30-day Notice
S057	2018-04-25	30-day Notice
S056	2018-04-06	30-day Notice
S055	2018-01-09	30-day Notice
S054	2018-01-04	135 Review Track For 30-day Notice
S053	2018-01-04	30-day Notice
S052
S051	2017-11-29	Normal 180 Day Track No User Fee
S050	2017-10-23	30-day Notice
S049	2017-09-07	30-day Notice
S048	2017-09-07	30-day Notice
S047	2017-09-07	30-day Notice
S046	2017-08-28	135 Review Track For 30-day Notice
S045
S044	2016-09-23	30-day Notice
S043	2016-07-18	30-day Notice
S042	2015-12-28	30-day Notice
S041	2015-11-20	30-day Notice
S040	2015-11-12	30-day Notice
S039	2015-05-28	30-day Notice
S038
S037	2015-03-02	Normal 180 Day Track No User Fee
S036	2014-07-11	Panel Track
S035	2014-06-02	30-day Notice
S034	2014-03-07	Real-time Process
S033	2013-12-31	30-day Notice
S032	2013-12-30	Normal 180 Day Track
S031	2013-07-03	30-day Notice
S030	2013-06-28	Real-time Process
S029	2013-04-11	30-day Notice
S028	2013-03-07	Normal 180 Day Track No User Fee
S027	2013-03-07	135 Review Track For 30-day Notice
S026	2012-11-20	Normal 180 Day Track
S025
S024	2012-10-11	Normal 180 Day Track No User Fee
S023	2012-09-24	30-day Notice
S022	2012-08-20	135 Review Track For 30-day Notice
S021	2012-07-12	Real-time Process
S020	2012-05-01	30-day Notice
S019	2012-04-06	Real-time Process
S018	2012-03-23	30-day Notice
S017	2012-02-01	30-day Notice
S016	2012-01-30	Real-time Process
S015	2012-01-19	Normal 180 Day Track No User Fee
S014	2011-10-07	30-day Notice
S013	2011-09-16	30-day Notice
S012
S011	2011-05-19	Normal 180 Day Track
S010	2011-01-28	Normal 180 Day Track
S009	2011-01-28	Normal 180 Day Track No User Fee
S008	2011-01-07	30-day Notice
S007
S006	2010-09-08	30-day Notice
S005	2010-08-11	135 Review Track For 30-day Notice
S004	2010-06-29	30-day Notice
S003	2010-04-20	30-day Notice
S002	2010-03-16	30-day Notice
S001	2010-02-23	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
10801741010023	P010047	000
20801741010037	P010047	008
10801741010016	P010047	010
10801741010009	P010047	010