CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP.
FDA premarket approval P890055/S062 · decided 2016-05-27
Approval details
- PMA number
- P890055
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP.
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2016-04-27
- Decision date
- 2016-05-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Change for a new packaging equipment to seal the pouches for the Codman 3000 Constant-Flow Implantable Infusion Pump O.R. Prep Kit Tubing Assembly. External supplier, Command Medical Products (Command), has requested implementation of new packaging sealing equipment, a Sencorp bar sealer (12-PL/2) with a removable work surface. The supplier has requested the change as a process improvement.
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