BSD-500 HYPERTHERMIA SYSTEM

FDA Premarket Approval P820088 S016

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 to replace the computer and monitor and for the minor upgrade for thermometry calibration method.

DeviceBSD-500 HYPERTHERMIA SYSTEM
Generic NameSystem, Rf/microwave Hyperthermia, Cancer Treatment
ApplicantPYREXAR MEDICAL INC
Date Received2003-04-21
Decision Date2003-10-08
PMAP820088
SupplementS016
Product CodeLOC 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address PYREXAR MEDICAL INC 2188 West 2200 South suite A salt Lake City, UT 84119

Supplemental Filings

Supplement NumberDateSupplement Type
P820088Original Filing
S017 2003-09-26 Normal 180 Day Track
S016 2003-04-21 Normal 180 Day Track
S015
S014 1991-09-23 Normal 180 Day Track
S013
S012
S011 1989-12-04 Normal 180 Day Track
S010
S009
S008 1989-04-14 Normal 180 Day Track
S007
S006 1987-02-03 Normal 180 Day Track
S005 1986-06-03 Normal 180 Day Track
S004 1985-04-23
S003 1984-09-04
S002 1983-11-28 Normal 180 Day Track
S001 1983-09-29

NIH GUDID Devices

Device IDPMASupp
08644450004342 P820088 016
00864445000434 P820088 016

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