PMA P990064S044
- Device
- MOSAIC PORCINE BIOPROSTHESIS
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S044
- Product code
- LWR
- Decision date
- 2012-12-19
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- MODIFICATION OF THE DIMENSIONS OF AN EXISTING CLEAN ROOM.
Current openFDA PMA Record#
- Device
- MOSAIC PORCINE BIOPROSTHESIS
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S044
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2012-12-19
- Decision code
- OK30
- Date received
- 2012-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION OF THE DIMENSIONS OF AN EXISTING CLEAN ROOM.