PMA P790007S040
- Device
- HANCOCK MODIFIED ORIFICE (MO) VALUED CONDUIT
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S040
- Product code
- LWR
- Decision date
- 2013-11-14
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO THE RUBBER GASKET FOR THE JAR USED TO PACKAGE THE DEVICE.
Current openFDA PMA Record#
- Device
- HANCOCK MODIFIED ORIFICE (MO) VALUED CONDUIT
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S040
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2013-11-14
- Decision code
- APPR
- Date received
- 2013-10-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A DESIGN CHANGE TO THE RUBBER GASKET FOR THE JAR USED TO PACKAGE THE DEVICE.