PMA P890017S018

Device
PALMAZ BALLOON EXPANDABLE STENT
Applicant
Cordis US Corporation
PMA number
P890017
Supplement
S018
Product code
NIN
Decision date
2016-09-28
Classification
Stent, Renal
Generic name
STENT, RENAL
Approval order statement
Approval for a change to the packaging materials for the PALMAZ Balloon-Expandable Stent.

Current openFDA PMA Record#

Device
PALMAZ BALLOON EXPANDABLE STENT
Applicant
Cordis US Corporation
PMA number
P890017
Supplement
S018
Product code
NIN
Generic name
STENT, RENAL
Decision date
2016-09-28
Decision code
APPR
Date received
2016-03-01
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a change to the packaging materials for the PALMAZ Balloon-Expandable Stent.