INTERPORE PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FILLER

FDA Premarket Approval P860005 S001

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.

Pre-market Approval Supplement Details

DeviceINTERPORE PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FILLER
Generic NameFiller, Bone Void, Non-osteoinduction
ApplicantINTERPORE INTL.
Date Received1993-02-08
Decision Date1994-03-17
PMAP860005
SupplementS001
Product CodeMBS 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address INTERPORE INTL. 181 Technology Dr. irvine, CA 92618-2402

Supplemental Filings

Supplement NumberDateSupplement Type
P860005Original Filing
S012 2001-12-04 Normal 180 Day Track
S011 1999-04-22 Normal 180 Day Track
S010 1997-11-18 Normal 180 Day Track
S009 1997-10-27 Normal 180 Day Track
S008 1997-08-28 Normal 180 Day Track
S007 1997-05-15 Normal 180 Day Track
S006
S005 1996-04-29 Normal 180 Day Track
S004 1994-02-22 Normal 180 Day Track
S003 1993-10-15 Normal 180 Day Track
S002 1993-03-23 Normal 180 Day Track
S001 1993-02-08 Normal 180 Day Track

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