MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator
FDA premarket approval P180025/S012 · decided 2024-06-07
Approval details
- PMA number
- P180025
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator
- Generic name
- Device, hemostasis, vascular
- Applicant
- Teleflex Medical, LLC
- Date received
- 2024-04-05
- Decision date
- 2024-06-07
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Morrisville, NC
- Statement
- Approval for the following manufacturing sites:Vascular Solutions LLC6464 Sycamore Court NorthMinneapolis, MN 55369Teleflex LLC North American Distribution Center (NADC)11245 N. Distribution CoveOlive Branch, MS 38654
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture (K261988) | Teleflex Medical, LLC | 2026-07-09 |
| Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ (K260775) | Teleflex Medical, LLC | 2026-05-06 |