VenaSeal Closure System
FDA premarket approval P140018/S018 · decided 2020-01-25
Approval details
- PMA number
- P140018
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VenaSeal Closure System
- Generic name
- Agent, occluding, vascular, permanent
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2019-10-28
- Decision date
- 2020-01-25
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- PJQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for an update to the instructions for use adding the option to deliver up to 3 aliquots of the device prior to compression.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
| Sentrant Introducer Sheath with Hydrophilic Coating (K171866) | Medtronic Vascular, Inc. | 2017-12-20 |
| SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System (K170191) | Medtronic Vascular, Inc. | 2017-06-16 |
| 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 |