PMA P990064S060

Device
MOSAIC PORCINE BIOPROSTHESIS
Applicant
Medtronic, Inc.
PMA number
P990064
Supplement
S060
Product code
LWR
Decision date
2014-12-02
Generic name
heart-valve, non-allograft tissue
Approval order statement
ADDITION OF A NEW PORCINE TISSUE SUPPLIER.

Current openFDA PMA Record#

Device
MOSAIC PORCINE BIOPROSTHESIS
Applicant
Medtronic, Inc.
PMA number
P990064
Supplement
S060
Product code
LWR
Generic name
heart-valve, non-allograft tissue
Decision date
2014-12-02
Decision code
OK30
Date received
2014-11-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A NEW PORCINE TISSUE SUPPLIER.