CODMAN 3000 SERIES CONSTANT-FLOW IMPLANTABLE INFUSION PUMP, MEDSTREAM REFILL KITS, SURESTREAM INTRASPINAL CATHETER KIT,C
FDA premarket approval P890055/S060 · decided 2015-07-23
Approval details
- PMA number
- P890055
- Supplement
- S060
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CODMAN 3000 SERIES CONSTANT-FLOW IMPLANTABLE INFUSION PUMP, MEDSTREAM REFILL KITS, SURESTREAM INTRASPINAL CATHETER KIT,C
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2015-06-24
- Decision date
- 2015-07-23
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- CHANGE IN THE VENDOR SUPPLIER THAT SUPPLIES THE TUBING FOR THE MEDSTREAM REFILL KIT AND MEDSTREAM BOLUS KIT AND A CHANGE IN THE FACILITY FOR MANUFACTURING OPERATIONS WITHIN THE SAME CAMPUS FOR THE VENDOR SUPPLIER THAT SUPPLIES THE TYVEK PACKAGING LIDS FOR THE CODMAN 3000 PUMP AND THE TYVEK RULERS FOR THE CODMAN INTRASPINAL CATHETER KITS.
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