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 | COBE CENTRY(R) TPE SYSTEM |
Generic Name | Separator, Automated, Blood Cell And Plasma, Therapeutic |
Applicant | GAMBRO BCT, INC. |
Date Received | 1993-04-19 |
Decision Date | 1994-07-05 |
PMA | P810023 |
Supplement | S002 |
Product Code | LKN |
Advisory Committee | Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | GAMBRO BCT, INC. 10811 West Collins Ave. lakewood, CO 80215 |
Supplement Number | Date | Supplement Type |
---|---|---|
P810023 | Original Filing | |
S002 | 1993-04-19 | Normal 180 Day Track |
S001 |