PMA P860019S226

Device
MAVERICK, MAVERICK2, MAVERICK XL, QUANTUM MAVERICK
Applicant
Scimed Life Systems, Inc.
PMA number
P860019
Supplement
S226
Product code
LOX
Decision date
2008-06-19
Classification
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement
ADDITION OF A NEW COMPUTER ASSISTED LABEL INSPECTION SYSTEM.

Current openFDA PMA Record#

Device
MAVERICK, MAVERICK2, MAVERICK XL, QUANTUM MAVERICK
Applicant
Scimed Life Systems, Inc.
PMA number
P860019
Supplement
S226
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
2008-06-19
Decision code
OK30
Date received
2008-05-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A NEW COMPUTER ASSISTED LABEL INSPECTION SYSTEM.