GRUNTZIG DILACA BALLOON DILATATION CATHETERS
FDA premarket approval P790017/S110 · decided 2010-10-27
Approval details
- PMA number
- P790017
- Supplement
- S110
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GRUNTZIG DILACA BALLOON DILATATION CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 2010-10-01
- Decision date
- 2010-10-27
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- TRANSFER OF POST STERILIZATION INSPECTIONS TO AN ALTERNATE SITE.
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