BSD-500 HYPERTHERMIA SYSTEM

FDA Premarket Approval P820088 S017

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 generator approved in pma p820088/s005. The device, as modified, will be marketed under the same trade name, bsd-500 hyperthermia system and is indicated for treatment of solid malignant tumors by localized heat delivery.

• Device: BSD-500 HYPERTHERMIA SYSTEM
• Generic Name: System, Rf/microwave Hyperthermia, Cancer Treatment
• Applicant: PYREXAR MEDICAL INC
• Date Received: 2003-09-26
• Decision Date: 2004-01-20
• PMA: P820088
• Supplement: S017
• Product Code: LOC
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: PYREXAR MEDICAL INC 2188 West 2200 South suite A salt Lake City, UT 84119

Supplemental Filings

Supplement Number	Date	Supplement Type
P820088		Original 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 ID	PMA	Supp
08644450004342	P820088	016
00864445000434	P820088	016