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 | AMIKACIN ELUTION DISK FOR AUTOBAC |
| Generic Name | Discs, Elution |
| Applicant | ORGANON TEKNIKA CORP. |
| Date Received | 1987-04-22 |
| Decision Date | 1987-08-10 |
| PMA | N50485 |
| Supplement | S015 |
| Product Code | LTX |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORGANON TEKNIKA CORP. 800 Capitola Dr. durham, NC 27713 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N50485 | Original Filing | |
| S017 | 1987-10-07 | Normal 180 Day Track |
| S016 | 1987-06-12 | Normal 180 Day Track |
| S015 | 1987-04-22 | Normal 180 Day Track |
| S014 | 1984-08-16 | |
| S013 | 1984-04-23 | Normal 180 Day Track |
| S012 | 1984-04-23 | Normal 180 Day Track |
| S011 | 1984-03-02 | |
| S010 | 1984-01-05 | |
| S009 | 1983-12-08 | |
| S008 | ||
| S007 | 1983-09-13 | |
| S006 | 1983-07-26 | |
| S005 | 1981-12-01 | |
| S004 | ||
| S003 | 1980-08-12 | |
| S002 | 1979-10-29 | |
| S001 | 1979-10-22 |