PMA P990064S048
- Device
- MOSAIC PORCINE BIOPROSTHESIS, MODELS 305 AND 310
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S048
- Product code
- LWR
- Decision date
- 2013-04-30
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- INSTALLATION OF A NEW COMPRESSED AIR SYSTEM.
Current openFDA PMA Record#
- Device
- MOSAIC PORCINE BIOPROSTHESIS, MODELS 305 AND 310
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S048
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2013-04-30
- Decision code
- OK30
- Date received
- 2013-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- INSTALLATION OF A NEW COMPRESSED AIR SYSTEM.