NEPTUNE X-ACT/NEPTUNE X-ACT OTW BALLOON DILATATION CATHETER
FDA premarket approval P790017/S073 · decided 2001-12-21
Approval details
- PMA number
- P790017
- Supplement
- S073
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NEPTUNE X-ACT/NEPTUNE X-ACT OTW BALLOON DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 2000-08-28
- Decision date
- 2001-12-21
- Days to decision
- 480 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL TO CHANGE THE SUPPLIER OF THE POLYETHYLENE TEREPHTHLATE (PET) ALLOY BALLOON TUBING USED IN THE MANUFACTURING OF THE DEVICES.
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