ProCol Vascular Bioprosthesis
FDA premarket approval P020049/S006 · decided 2018-09-28
Approval details
- PMA number
- P020049
- Supplement
- S006
- 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
- 2018-06-29
- Decision date
- 2018-09-28
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LXA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Burlington, MA
- Statement
- for a manufacturing site located at Isomedix Operations, Inc., 435 Whitney Street, Northborough, Massachusetts, for sterilization of the ProCol Vascular Bioprothesis
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| 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (K140042) | LeMaitre Vascular, Inc. | 2014-04-10 |
| UNBALLOON NON-OCCLUSION MODELING CATHETER (K133026) | LeMaitre Vascular, Inc. | 2013-12-31 |