PROCOL VASCULAR BIOPROSTHESIS
FDA premarket approval P020049 · decided 2003-07-29
Approval details
- PMA number
- P020049
- Trade name
- PROCOL VASCULAR BIOPROSTHESIS
- Generic name
- Tissue graft of 6mm and greater
- Applicant
- LeMaitre Vascular, Inc.
- Date received
- 2002-11-12
- Decision date
- 2003-07-29
- Days to decision
- 259 days
- Decision code
- APWD
- Product code
- LXA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burlington, MA
- Statement
- APPROVAL FOR THE PROCOL VASCULAR BIOPROSTHESIS. THE DEVICE IS INDICATED FOR THE CREATION OF A BRIDGE GRAFT FOR VASCULAR ACCESS SUBSEQUENT TO AT LEAST ONE PREVIOUSLY FAILED PROSTHETIC ACCESS GRAFT.
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