GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER, NC STORMER MX2
FDA premarket approval P790017/S091 · decided 2007-08-30
Approval details
- PMA number
- P790017
- Supplement
- S091
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER, NC STORMER MX2
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 2007-08-01
- Decision date
- 2007-08-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- REDUCTION IN THE NUMBER OF SAMPLES SUBMITTED FOR END OF LINE QUALITY CONTROL FUNCTION TESTING OF THE DEVICE.
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