CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
FDA premarket approval P900060/S029 · decided 2004-07-02
Approval details
- PMA number
- P900060
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Corcym S.r.l.
- Date received
- 2004-06-14
- Decision date
- 2004-07-02
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- CHANGE IN THE MANUFACTURING PROCESS TO THE STERILIZATION PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN A BIOLOGICAL INDICATOR.
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