PMA P020047S058

Device: MULTI-LINK VISION CORONARY STENT SYSTEMS, MULTI-LINK MINI VISION CORONARY STENT SYSTEMS, MULTI-LINK 8 CONONARY STENT
Applicant: Abbott Vascular
PMA number: P020047
Supplement: S058
Product code: MAF
Decision date: 2014-05-13
Classification: Stent, Coronary
Generic name: STENT, CORONARY
Approval order statement: ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF RAW MATERIALS AND SUPPLY ITEMS AT THE CLONMEL, IRELAND FACILITY AND CONTRACT LABORATORIES.

Current openFDA PMA Record#

Device: MULTI-LINK VISION CORONARY STENT SYSTEMS, MULTI-LINK MINI VISION CORONARY STENT SYSTEMS, MULTI-LINK 8 CONONARY STENT
Applicant: Abbott Vascular
PMA number: P020047
Supplement: S058
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2014-05-13
Decision code: OK30
Date received: 2014-04-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF RAW MATERIALS AND SUPPLY ITEMS AT THE CLONMEL, IRELAND FACILITY AND CONTRACT LABORATORIES.