PMA P020009S081

Device
EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM
Applicant
Boston Scientific Scimed, Inc.
PMA number
P020009
Supplement
S081
Product code
MAF
Decision date
2012-03-02
Generic name
STENT, CORONARY
Approval order statement
CHANGE TO THE BALLOON DRYING PROCESS.

Current openFDA PMA Record#

Device
EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM
Applicant
Boston Scientific Scimed, Inc.
PMA number
P020009
Supplement
S081
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2012-03-02
Decision code
OK30
Date received
2012-02-03
Supplement type
30-Day Notice
Approval order statement
CHANGE TO THE BALLOON DRYING PROCESS.