PMA N5798

Device
OXYCELL
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
PMA number
N5798
Supplement
S007
Product code
LMG
Decision date
1995-07-24
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
APPROVAL FOR A CHANGE IN THE QUALITY CONTROL PROCEDURES FOR POST-STERILIZATION LOTS OF OXYCEL

Current openFDA PMA Record#

Device
OXYCELL
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
PMA number
N5798
Supplement
S007
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
1995-07-24
Decision code
APPR
Date received
1995-02-16
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A CHANGE IN THE QUALITY CONTROL PROCEDURES FOR POST-STERILIZATION LOTS OF OXYCEL