PROCOL VASCULAR BIOPROSTHESIS
FDA premarket approval P020049/S003 · decided 2014-09-29
Approval details
- PMA number
- P020049
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROCOL VASCULAR BIOPROSTHESIS
- Generic name
- Tissue graft of 6mm and greater
- Applicant
- LeMaitre Vascular, Inc.
- Date received
- 2014-07-11
- Decision date
- 2014-09-29
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LXA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burlington, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN IRVINE, CALIFORNIA.
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