Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | PORT-A-CATH EPIDURAL SYSTEMS |
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 | S009 |
Date Received | 09/11/2001 |
Decision Date | 10/01/2001 |
Withdrawal Date
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12/26/2018 |
Product Code |
LNY |
Advisory Committee |
General Hospital |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement ELIMINATE THE INSPECTION PROCEDURE ON SOME INCOMING COMPONENTS USED IN THE MANUFACTURE OF THE PORT-A-CATH(R) EPIDURAL SYSTEMS. |
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