INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4

FDA Premarket Approval P800036

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

DeviceINFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
Generic NamePump, Infusion, Implanted, Programmable
ApplicantIntera Oncology
Date Received1980-06-23
Decision Date1982-03-03
Notice Date1982-03-26
PMAP800036
SupplementS
Product CodeLKK 
Docket Number82M-0072
Advisory CommitteeGeneral Hospital
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
10886704044093 P800036 000
10886704044109 P800036 024
10886704078845 P800036 024
10886704044086 P800036 037

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