LUTONIX DRUG COATED BALLOON
FDA premarket approval P130024/S003 · decided 2015-11-23
Approval details
- PMA number
- P130024
- Supplement
- S003
- Supplement type
- 135 Review Track For 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
- 2015-02-25
- Decision date
- 2015-11-23
- Days to decision
- 271 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- APPROVAL TO CHANGE THE PARTICULATE SPECIFICATION FOR THE DEVICE AT LOT RELEASE AND STABILITY TESTING.
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