PMA P860064S008

Device: DUPEN LONG TERM EPIDURAL CATHETER
Applicant: C.R. Bard, Inc.
PMA number: P860064
Supplement: S008
Product code: LNY
Decision date: 1997-08-08
Classification: Catheter, Percutaneous, Long Term, Intraspinal
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
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.

Current openFDA PMA Record#

Device: DUPEN LONG TERM EPIDURAL CATHETER
Applicant: C.R. Bard, Inc.
PMA number: P860064
Supplement: S008
Product code: LNY
Generic name: CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Decision date: 1997-08-08
Decision code: APPR
Date received: 1997-05-05
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
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.