PMA P120020S015

Device
SUPERA PERIPHERAL STENT SYSTEM
Applicant
Abbott Vascular (Idef Technologies Inc)
PMA number
P120020
Supplement
S015
Product code
NIP
Decision date
2016-10-06
Classification
Stent, Superficial Femoral Artery
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
Changes to the sampling for lot release testing.

Current openFDA PMA Record#

Device
SUPERA PERIPHERAL STENT SYSTEM
Applicant
Abbott Vascular (Idef Technologies Inc)
PMA number
P120020
Supplement
S015
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2016-10-06
Decision code
OK30
Date received
2016-09-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the sampling for lot release testing.