IN PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMICAL ANGIOPLASTLY BALLOON CATHETER
FDA premarket approval P140010/S007 · decided 2015-07-24
Approval details
- PMA number
- P140010
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IN PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMICAL ANGIOPLASTLY BALLOON CATHETER
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Applicant
- Medtronic, Inc.
- Date received
- 2015-07-10
- Decision date
- 2015-07-24
- Days to decision
- 14 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 FREEPAC COATING SOLUTION FROM 7 TO 14 DAYS.
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