GRUNTZIG DILACA BALLOON DILATATION CATHETERS
FDA premarket approval P790017/S102 · decided 2009-12-30
Approval details
- PMA number
- P790017
- Supplement
- S102
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GRUNTZIG DILACA BALLOON DILATATION CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 2009-11-09
- Decision date
- 2009-12-30
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON IRELAND LTD., OFFALY, IRELAND.
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