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 | DUPEN LONG TERM EPIDURAL CATHETER |
Generic Name | CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
Applicant | C.R. Bard, Inc. 605 N 5600 W SALT LAKE CITY, UT 84116 |
PMA Number | P860064 |
Supplement Number | S008 |
Date Received | 05/05/1997 |
Decision Date | 08/08/1997 |
Withdrawal Date
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05/20/2020 |
Product Code |
LNY |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE STERILANT FORM 12% FREON/ 88% ETHYLENE OSIDE TO 100% ETHYLENE OXIDE AND TO CHANGE THE STERILIZATION FACILITY FROM DAVOL, INC., A C.R. BARD FACILITY IN CRANSTON, R.I., TO A CONTRACT STERILIZER, SOREX MEDICAL, INC., IN SALT LAKE CITY, UTAH. |
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