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 | AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG |
Generic Name | Implant, Endosseous, Root-form |
Applicant | CURASAN AG |
Date Received | 1983-10-11 |
Decision Date | 1983-11-10 |
PMA | P800035 |
Supplement | S008 |
Product Code | DZE |
Advisory Committee | Dental |
Expedited Review | No |
Combination Product | No |
Applicant Address | CURASAN AG lindigstrasse 4 kleinostheim D-638-6380 |
Supplement Number | Date | Supplement Type |
---|---|---|
P800035 | Original Filing | |
S011 | 2002-04-05 | Normal 180 Day Track |
S010 | 2001-06-25 | Normal 180 Day Track |
S009 | ||
S008 | 1983-10-11 | |
S007 | 1983-09-13 | |
S006 | ||
S005 | 1982-06-15 | |
S004 | 1982-12-20 | |
S003 | 1982-10-22 | |
S002 | 1982-06-30 | |
S001 | 1981-12-14 |