PMA P790007S027
- Device
- HANCOCK I MODIFIED ORIFICE VALVED CONDUIT MODEL 150
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S027
- Product code
- LWR
- Decision date
- 2010-11-19
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- ADDITION OF A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
Current openFDA PMA Record#
- Device
- HANCOCK I MODIFIED ORIFICE VALVED CONDUIT MODEL 150
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S027
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2010-11-19
- Decision code
- OK30
- Date received
- 2010-10-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.