OVER THE WIRE DILATATION CATHETERS
FDA premarket approval P790017/S068 · decided 1999-01-08
Approval details
- PMA number
- P790017
- Supplement
- S068
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OVER THE WIRE DILATATION CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 1998-12-10
- Decision date
- 1999-01-08
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- The 30-Day Notice requested to modify the sterilization parameters to address the excessively long Ethylene Oxide residue quarantine times by reducing as exposure minor modifications to the sterilization parameters are also being introduced to improve efficiency and increase flexibility at the contract sterilization facility.
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|---|---|---|
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| ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM (K061480) | Medtronic, Ireland | 2006-08-21 |
| ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM (K053431) | Medtronic, Ireland | 2006-03-16 |