Model 400 Implantable Infusion Pump

FDA Premarket Approval P800036 S039

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 modifications associated with accessories for p800036 and p890055: needles: needle drawing changes and process control improvements at the supplier; and luer adaptor: supplier manufacturing site changes.

• Device: Model 400 Implantable Infusion Pump
• Generic Name: Pump, Infusion, Implanted, Programmable
• Applicant: Intera Oncology
• Date Received: 2016-08-02
• Decision Date: 2016-08-29
• PMA: P800036
• Supplement: S039
• Product Code: LKK
• Advisory Committee: General Hospital
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: Intera Oncology 65 William Street suite 2000 wellesley, MA 02481

Supplemental Filings

Supplement Number	Date	Supplement Type
P800036		Original Filing
S041	2020-01-09	Normal 180 Day Track No User Fee
S040	2017-06-08	30-day Notice
S039	2016-08-02	30-day Notice
S038	2014-06-27	Normal 180 Day Track No User Fee
S037	2010-11-24	30-day Notice
S036	2006-04-21	Normal 180 Day Track No User Fee
S035	1997-10-21	Normal 180 Day Track
S034	1997-09-04	Normal 180 Day Track
S033
S032	1995-07-12	Normal 180 Day Track
S031	1994-03-08	Normal 180 Day Track
S030	1993-12-29	Normal 180 Day Track
S029	1992-05-18	Normal 180 Day Track
S028
S027
S026
S025	1990-06-19	Normal 180 Day Track
S024	1990-05-29	Normal 180 Day Track
S023
S022
S021	1989-06-12	Normal 180 Day Track
S020
S019	1989-01-23	Normal 180 Day Track
S018	1988-12-28	Normal 180 Day Track
S017
S016	1987-11-17	Normal 180 Day Track
S015	1987-09-16	Normal 180 Day Track
S014
S013	1985-12-10	Panel Track
S012	1984-09-12
S011	1984-09-20
S010
S009	1984-05-07
S008	1984-05-03
S007	1984-01-31
S006	1983-08-26
S005	1983-06-22
S004	1983-02-22
S003	1983-02-22
S002	1982-07-12
S001	1982-03-10	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
10886704044093	P800036	000
10886704044109	P800036	024
10886704078845	P800036	024
10886704044086	P800036	037