NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE
FDA premarket approval P790017/S067 · decided 1998-09-18
Approval details
- PMA number
- P790017
- Supplement
- S067
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION ACATHETER WITH HYDRO/PEL COATING AND ANTI BACK BLEED DEVICE
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 1998-03-23
- Decision date
- 1998-09-18
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- Approval to market new PTCA catheter models. The devices, as modified, will be marketed under the trade names USCI(R) Neptune(TM) X-act(R) and the Neptune(TM) X-act(R) Duo Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel(R) Coating and Anti Back Bleed Device and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
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