USCI(R)GRUNTZIG DILACA CATHETER
FDA premarket approval P790017/S052 · decided 1996-04-18
Approval details
- PMA number
- P790017
- Supplement
- S052
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- USCI(R)GRUNTZIG DILACA CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 1993-06-23
- Decision date
- 1996-04-18
- Days to decision
- 1030 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL FOR A STERILIZATION SITE CHANGE AND A CHANGE IN THE STERILIZATION CYCLE
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