Ranger Paclitaxel-Coated PTA Balloon Catheter
FDA premarket approval P190019/S028 · decided 2024-03-19
Approval details
- PMA number
- P190019
- Supplement
- S028
- 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
- 2024-02-21
- Decision date
- 2024-03-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- modifications to lot release testing and reserve sampling
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510(k) clearances by this applicant
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