NC STORMER OTW BALLOON DILATATION CATHETER
FDA premarket approval P790017/S084 · decided 2005-10-17
Approval details
- PMA number
- P790017
- Supplement
- S084
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NC STORMER OTW BALLOON DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 2005-09-23
- Decision date
- 2005-10-17
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- CHANGE WHICH WOULD INCREASE THE LENGTH OF THE DISTAL OUTER SHAFT OF NC STORMER OTW BALLOON DILATATION CATHETER FROM 21.5 CM - 23.5 CM TO 23.0 CM - 24.0 CM.
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