PMA P790007S023
- Device
- HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT, MODELS 105 AND 150
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S023
- Product code
- LWR
- Decision date
- 2009-11-03
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- ADDITION OF ALTERNATE MATERIAL SUPPLIERS.
Current openFDA PMA Record#
- Device
- HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT, MODELS 105 AND 150
- Applicant
- Medtronic Heart Valves
- PMA number
- P790007
- Supplement
- S023
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2009-11-03
- Decision code
- OK30
- Date received
- 2009-10-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF ALTERNATE MATERIAL SUPPLIERS.