PMA P000007S030

Device
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
Applicant
Edwards Lifesciences, LLC
Product code
DYE
Decision date
2012-04-13
Generic name
replacement Heart-valve
Approval order statement
NEW SUPPLIER FOR SELVEDGE YARN.

Current openFDA PMA Record

Device
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
Applicant
Edwards Lifesciences, LLC
PMA number
P000007
Supplement
S030
Product code
DYE
Generic name
replacement Heart-valve
Decision date
2012-04-13
Decision code
OK30
Date received
2012-03-20
Supplement type
30-Day Notice
Approval order statement
NEW SUPPLIER FOR SELVEDGE YARN.

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