IN-PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
FDA premarket approval P140010/S006 · decided 2015-06-24
Approval details
- PMA number
- P140010
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IN-PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Medtronic, Inc.
- Date received
- 2015-04-21
- Decision date
- 2015-06-24
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- ONU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- APPROVAL FOR AN EXTENSION OF THE SHELF LIFE OF THE PRODUCT FROM 12 TO 24 MONTHS.
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