VenaSeal Closure System
FDA premarket approval P140018/S006 · decided 2017-08-22
Approval details
- PMA number
- P140018
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VenaSeal Closure System
- Generic name
- Agent, occluding, vascular, permanent
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2017-05-18
- Decision date
- 2017-08-22
- Days to decision
- 96 days
- Decision code
- APPR
- Product code
- PJQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for a manufacturing site located at Medtronic Ireland Parkmore Business Park West Galway, Ireland for manufacturing activities and final release of product.
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|---|---|---|
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
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| Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (K171427) | Medtronic Vascular, Inc. | 2017-06-13 |
| HawkOne Directional Atherectomy System (K161361) | Medtronic Vascular, Inc. | 2016-10-14 |