FLEXTIP PLUS INTRASPINAL CATHETER KIT
FDA premarket approval P890055/S024 · decided 2007-12-18
Approval details
- PMA number
- P890055
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FLEXTIP PLUS INTRASPINAL CATHETER KIT
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2007-11-19
- Decision date
- 2007-12-18
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- CHANGE TO: 1) THE PACKAGING LOCATION FROM AVID MEDICAL TO CODMAN & SHURTLEFF, INC.; 2) THE PACKAGING COMPONENT SUPPLIERS; AND 3) THE TOUHY NEEDLES AND RULER SUPPLIERS.
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