PMA P990064S030
- Device
- MOSAIC PORCINE BIOPROSTHESIS
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S030
- Product code
- DYE
- Decision date
- 2010-03-15
- Generic name
- replacement Heart-valve
- Approval order statement
- APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
Current openFDA PMA Record#
- Device
- MOSAIC PORCINE BIOPROSTHESIS
- Applicant
- Medtronic, Inc.
- PMA number
- P990064
- Supplement
- S030
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2010-03-15
- Decision code
- APPR
- Date received
- 2010-01-06
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR VERSION 8.1.1 MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.