PMA P900060S039
- Device
- CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
- Applicant
- Corcym S.r.l.
- PMA number
- P900060
- Supplement
- S039
- Product code
- LWQ
- Decision date
- 2007-11-30
- 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
- S039
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2007-11-30
- Decision code
- APPR
- Date received
- 2007-06-19
- 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.