FLEX TIP INTRASPINAL KIT, CATALOG AP-07008
FDA premarket approval P890055/S005 · decided 1998-12-23
Approval details
- PMA number
- P890055
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FLEX TIP INTRASPINAL KIT, CATALOG AP-07008
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 1997-09-09
- Decision date
- 1998-12-23
- Days to decision
- 470 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for the Flex tip Plus Intraspinal Catheter Kit, Catalog AP-07008. This Catheter Kit will be used with the model 3000 Implantable Pump with Bolus Safety Valve for intraspinal delivery of preservative free morphine to patients with chronic intractable pain.
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