OXYCELL

FDA Premarket Approval N5798 S007

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

Approval for a change in the quality control procedures for post-sterilization lots of oxycel

DeviceOXYCELL
Generic NameAgent, Absorbable Hemostatic, Non-collagen Based
ApplicantBD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
Date Received1995-02-16
Decision Date1995-07-24
PMAN5798
SupplementS007
Product CodeLMG 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC one Becton Dr. franklin Lakes, NJ 07417-1880

Supplemental Filings

Supplement NumberDateSupplement Type
N5798Original Filing
S007 1995-02-16 Normal 180 Day Track
S006 1990-12-19 Normal 180 Day Track
S005 1988-09-21 Normal 180 Day Track
S004 1983-04-21
S003 1982-06-29
S002 1980-10-29
S001 1980-10-27

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