Ranger Paclitaxel-Coated PTA Balloon Catheter
FDA premarket approval P190019/S018 · decided 2023-03-02
Approval details
- PMA number
- P190019
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Ranger Paclitaxel-Coated PTA Balloon Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Boston Scientific Corporation
- Date received
- 2022-12-07
- Decision date
- 2023-03-02
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for a change to an alternate supplier of an equivalent resin used as the middle layer in the tri-layer inner component of your stents delivery system.
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