INFUSAID Implantable Infusion Pump and Accessories

FDA Premarket Approval P800036 S041

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

Based upon the information submitted, the pma supplement is approved.

DeviceINFUSAID Implantable Infusion Pump and Accessories
Generic NamePump, Infusion, Implanted, Programmable
ApplicantIntera Oncology
Date Received2020-01-09
Decision Date2020-02-07
PMAP800036
SupplementS041
Product CodeLKK 
Advisory CommitteeGeneral Hospital
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Intera Oncology 65 William Street suite 2000 wellesley, MA 02481

Supplemental Filings

Supplement NumberDateSupplement Type
P800036Original 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 IDPMASupp
10886704044109 P800036 024

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