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/II EPIDURAL LOW PROFILE 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 | S007 |
Date Received | 02/11/1999 |
Decision Date | 04/21/1999 |
Withdrawal Date
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12/26/2018 |
Product Code |
LNY |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in the postapproval protocol to allow the use of Low Profile system which was approved on 10/28/98. |
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