Lutonix 035 Drug Coated Balloon PTA Catheter
FDA premarket approval P170003/S008 · decided 2019-06-24
Approval details
- PMA number
- P170003
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Lutonix 035 Drug Coated Balloon PTA Catheter
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Applicant
- Lutonix
- Date received
- 2019-04-25
- Decision date
- 2019-06-24
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- PRC
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- New Hope, MN
- Statement
- Approval of the changes to the Informed Consent Form for the New Enrollment PAS Registry.
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