SYNCHROMED II PUMP
FDA premarket approval P860004/S095 · decided 2007-12-11
Approval details
- PMA number
- P860004
- Supplement
- S095
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNCHROMED II PUMP
- Applicant
- Medtronic, Inc.
- Date received
- 2007-11-23
- Decision date
- 2007-12-11
- Days to decision
- 18 days
- Decision code
- OK30
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE JUNCOS, PUERTO RICO MANUFACTURING FACILITY.
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