|
Device | PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM |
Generic Name | CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
Applicant | SMITHS MEDICAL ASD, INC. 1265 Grey Fox Road St. Paul, MN 55112 |
PMA Number | P900052 |
Supplement Number | S013 |
Date Received | 07/26/2006 |
Decision Date | 04/05/2007 |
Withdrawal Date
|
12/26/2018 |
Product Code |
LNY |
Advisory Committee |
General Hospital |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A SECOND OPERATOR INSPECTION FOR OUTLET TUBE AND INSERT HOLE ALIGNMENT TO CONFIRM PROPER ALIGNMENT OF THE OUTLET TUBE. |