SPRINTER OVER-THE-WIRE BALLOON DILATATION CATHETER
FDA premarket approval P790017/S087 · decided 2007-08-22
Approval details
- PMA number
- P790017
- Supplement
- S087
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPRINTER OVER-THE-WIRE BALLOON DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 2007-07-23
- Decision date
- 2007-08-22
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- ADDING THE OPTION TO STERILIZE THE SUBJECT DEVICE TWICE.
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510(k) clearances by this applicant
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|---|---|---|
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