LUTONIX DRUG COATED BALLOON
FDA premarket approval P130024/S017 · decided 2016-12-16
Approval details
- PMA number
- P130024
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LUTONIX DRUG COATED BALLOON
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2016-11-28
- Decision date
- 2016-12-16
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Modifications to the annual stability monitoring protocol and associated test methods.
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