DUPEN LONG TERM EPIDURAL CATHETER
FDA premarket approval P860064/S008 · decided 1997-08-08
Approval details
- PMA number
- P860064
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DUPEN LONG TERM EPIDURAL CATHETER
- Generic name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Applicant
- C.R. Bard, Inc.
- Date received
- 1997-05-05
- Decision date
- 1997-08-08
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Salt Lake Ciy,, UT
- 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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