DUPEN LONG-TERM EPIDURAL CATHETER
FDA premarket approval P860064/S010 · decided 2001-12-07
Approval details
- PMA number
- P860064
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2001-11-14
- Decision date
- 2001-12-07
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LNY
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Salt Lake Ciy,, UT
- Statement
- MANUFACTURING CHANGE IN ETO STERILIZATION CYCLE PARAMETERS.
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