MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
FDA premarket approval P890055/S016 · decided 2003-08-12
Approval details
- PMA number
- P890055
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2003-07-16
- Decision date
- 2003-08-12
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES: 1) REPLACE THE CURRENTLY APPROVED CATHETER KIT (AP-07002) WITH THE IP-36633 AND IP-3757 KITS, 2) REPLACE IP-36633 AND IP-3757 CONNECTOR WITH CODMAN 3000 (AP-07002) CONNECTOR, AND INCLUDE TITANIUM AS AN ALTERNATIVE CONNECTOR MATERIAL, 3) ADD ADDITIONAL COMPONENTS TO THE KIT AS A CONVENIENCE TO THE PHYSICIANS AND 4) LABELING CHANGE TO THE FLEXTIP PLUS INTRASPINAL CATHETER KIT INSTRUCTIONS FOR USE TO REFLECT THE CORRECT CATHETER VOLUME.
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