PMA P990064S033

Device
MOSAIC PORCINE BIOPROSTHESIS MODELS 305/310/305U
Applicant
Medtronic, Inc.
PMA number
P990064
Supplement
S033
Product code
DYE
Decision date
2010-05-28
Generic name
replacement Heart-valve
Approval order statement
ADDITION OF GORDITOS MEATS AS AN ALTERNATE SUPPLIER.

Current openFDA PMA Record#

Device
MOSAIC PORCINE BIOPROSTHESIS MODELS 305/310/305U
Applicant
Medtronic, Inc.
PMA number
P990064
Supplement
S033
Product code
DYE
Generic name
replacement Heart-valve
Decision date
2010-05-28
Decision code
OK30
Date received
2010-04-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF GORDITOS MEATS AS AN ALTERNATE SUPPLIER.