GRUNTZIG DILACA BALLOON DILATATION CATHETERS
FDA premarket approval P790017/S101 · decided 2009-11-12
Approval details
- PMA number
- P790017
- Supplement
- S101
- 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
- 2009-10-13
- Decision date
- 2009-11-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- MODIFICATION TO THE E-BEAM STERILIZATION DOSE AUDIT FREQUENCY.
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