PMA P900060S037

Device
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Applicant
Corcym S.r.l.
PMA number
P900060
Supplement
S037
Product code
LWQ
Decision date
2006-11-03
Classification
Heart-valve, Mechanical
Generic name
HEART-VALVE, MECHANICAL
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SORIN BIOMEDICA CARDIO S.R.L., SALUGGIA (VERCELLI), ITALY.

Current openFDA PMA Record#

Device
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Applicant
Corcym S.r.l.
PMA number
P900060
Supplement
S037
Product code
LWQ
Generic name
HEART-VALVE, MECHANICAL
Decision date
2006-11-03
Decision code
APPR
Date received
2006-10-10
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SORIN BIOMEDICA CARDIO S.R.L., SALUGGIA (VERCELLI), ITALY.