Medstream Programmable Infusion System
FDA premarket approval P890055/S063 · decided 2016-08-18
Approval details
- PMA number
- P890055
- Supplement
- S063
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Medstream Programmable Infusion System
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2016-07-19
- Decision date
- 2016-08-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Move downstream manufacturing processes from the Medos International facility located at Chemin Blanc, Le Locle, Switzerland to Codman Neuro Sciences located at Rue Girardet, Le Locle, Switzerland.
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