PMA P000033

Device
INTRACOIL SELF-EXPANDING PERIPHERAL STENT
Applicant
Medtronic Vascular, Inc.
PMA number
P000033
Supplement
S002
Product code
NIP
Decision date
2005-07-07
Classification
Cardiovascular
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement
CHANGE IN THE MANUFACTURING PROCESS TO THE LABEL PRINTING AND LABEL VERIFICATION PROCESS.

Current openFDA PMA Record#

Device
INTRACOIL SELF-EXPANDING PERIPHERAL STENT
Applicant
Medtronic Vascular, Inc.
PMA number
P000033
Supplement
S002
Product code
NIP
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Decision date
2005-07-07
Decision code
OK30
Date received
2005-06-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE MANUFACTURING PROCESS TO THE LABEL PRINTING AND LABEL VERIFICATION PROCESS.