Hancock Valved Conduit, Model 105
FDA premarket approval P870078/S036 · decided 2017-08-09
Approval details
- PMA number
- P870078
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Hancock Valved Conduit, Model 105
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 2017-07-10
- Decision date
- 2017-08-09
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Implement additional test samples for solution chemistry and sterility as part of the routine monitoring and lot release performed for terminal liquid sterilization.
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