LUTONIX 035 DRUG COATED BALLOON PTA CATETER
FDA premarket approval P130024/S013 · decided 2016-11-09
Approval details
- PMA number
- P130024
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LUTONIX 035 DRUG COATED BALLOON PTA CATETER
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Lutonix
- Date received
- 2016-06-15
- Decision date
- 2016-11-09
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval for a manufacturing site located at Lutonix Inc., 9409 Science Center Drive, New Hope, Minnesota to manufacture 7mm balloons.
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