PMA P900039S012

Device: COLLAGRAFT STRIP BONE GRAFT MATRIX
Applicant: Neucoll, Inc.
PMA number: P900039
Supplement: S012
Product code: MBS
Decision date: 2002-10-10
Generic name: Filler, bone void, non-osteoinduction
Approval order statement: CHANGE IN THE DEFINITION OF A SAMPLE ITEM PORTION (SIP) FROM A STRIP ALONE TO A STRIP PLUS INNER PACKAGING (INNER TRAY, INNER TRAY LID, LIFT TAB, AND TRAY RETAINER). ONLY A SINGLE SIP MAY BE SOURCED FROM EACH TRAY.

Current openFDA PMA Record#

Device: COLLAGRAFT STRIP BONE GRAFT MATRIX
Applicant: Neucoll, Inc.
PMA number: P900039
Supplement: S012
Product code: MBS
Generic name: Filler, bone void, non-osteoinduction
Decision date: 2002-10-10
Decision code: OK30
Date received: 2002-09-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE DEFINITION OF A SAMPLE ITEM PORTION (SIP) FROM A STRIP ALONE TO A STRIP PLUS INNER PACKAGING (INNER TRAY, INNER TRAY LID, LIFT TAB, AND TRAY RETAINER). ONLY A SINGLE SIP MAY BE SOURCED FROM EACH TRAY.