Ranger Paclitaxel-Coated PTA Balloon Catheter
FDA premarket approval P190019/S016 · decided 2022-11-15
Approval details
- PMA number
- P190019
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ranger Paclitaxel-Coated PTA Balloon Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Boston Scientific Corporation
- Date received
- 2022-10-17
- Decision date
- 2022-11-15
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Change to a sterilization Chamber at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility.
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510(k) clearances by this applicant
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