USCI(R) SOLO(TM) BALL. DIL. CATH. W/PRO/PEL COAT
FDA premarket approval P790017/S041 · decided 1992-10-20
Approval details
- PMA number
- P790017
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- USCI(R) SOLO(TM) BALL. DIL. CATH. W/PRO/PEL COAT
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 1991-11-19
- Decision date
- 1992-10-20
- Days to decision
- 336 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
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