PMA P790007S024
- Device
- HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S024
- Product code
- LWR
- Decision date
- 2010-03-15
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
Current openFDA PMA Record#
- Device
- HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S024
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2010-03-15
- Decision code
- APPR
- Date received
- 2010-01-06
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.