PMA P020047S031

Device
MULTI-LINK VISION/MINI VISION/8TM/8TMLL/8TM SV CORONARY STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S031
Product code
MAF
Decision date
2011-03-18
Classification
Stent, Coronary
Generic name
STENT, CORONARY
Approval order statement
CHANGE IN QUALITY CONTROL TESTING FOR BALLOON RUPTURE.

Current openFDA PMA Record#

Device
MULTI-LINK VISION/MINI VISION/8TM/8TMLL/8TM SV CORONARY STENT SYSTEM
Applicant
Abbott Vascular
PMA number
P020047
Supplement
S031
Product code
MAF
Generic name
STENT, CORONARY
Decision date
2011-03-18
Decision code
OK30
Date received
2011-03-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN QUALITY CONTROL TESTING FOR BALLOON RUPTURE.