MITROFLOW AORTIC PERICARDIAL HEART VALVE
FDA premarket approval P060038/S001 · decided 2008-07-25
Approval details
- PMA number
- P060038
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MITROFLOW AORTIC PERICARDIAL HEART VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym Canada Corp
- Date received
- 2008-04-02
- Decision date
- 2008-07-25
- Days to decision
- 114 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burnaby
- Statement
- APPROVAL FOR: 1) CHANGES TO THE INCOMING INSPECTION CRITERIA FOR THE RAW MATERIAL USED TO MANUFACTURE THE STENT COMPONENT; 2) THE ADDITION OF A NEW SUPPLIER FOR ANALYTICAL RESTING OF THIS RAW MATERIAL; AND 3) CHANGES TO THE VISUAL INSPECTION PROCESS FOR THE STENT COMPONENT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.