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.
| Device | BSD 1000 HYPERTHERMIA SYSTEM |
| Generic Name | System, Rf/microwave Hyperthermia, Cancer Treatment |
| Applicant | PYREXAR MEDICAL INC |
| Date Received | 1989-04-14 |
| Decision Date | 1991-03-28 |
| PMA | P820088 |
| Supplement | S008 |
| 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 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 08644450004342 | P820088 | 016 |
| 00864445000434 | P820088 | 016 |