PERI-OSS

FDA Premarket Approval P800035

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DevicePERI-OSS
Generic NameBone Grafting Material, For Dental Bone Repair
ApplicantCURASAN AG
Date Received1980-06-12
Decision Date1981-03-24
Notice Date1981-04-13
PMAP800035
SupplementS
Product CodeLPK 
Advisory CommitteeDental
Expedited ReviewNo
Combination Product No
Applicant Address CURASAN AG lindigstrasse 4 kleinostheim D-638-6380

Supplemental Filings

Supplement NumberDateSupplement Type
P800035Original 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

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