GEM MODEL 7227 IMPLANTABLE DEVICE
FDA premarket approval P890055/S021 · decided 2007-09-07
Approval details
- PMA number
- P890055
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM MODEL 7227 IMPLANTABLE DEVICE
- Generic name
- Pump, infusion, implanted, programmable
- Applicant
- Intera Oncology
- Date received
- 2007-08-06
- Decision date
- 2007-09-07
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LKK
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIS-ISOMEDIX, NORTHBOROUGH, MASSACHUSETTS.
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