TELESCOPE PTCA BALLOON CATHETER
FDA premarket approval P790017/S064 · decided 1998-02-12
Approval details
- PMA number
- P790017
- Supplement
- S064
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TELESCOPE PTCA BALLOON CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 1998-01-20
- Decision date
- 1998-02-12
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- Approval to sell the USCI(R) Telescope(TM) Balloon Dilatation Catheter with Hydro/Pel(R) Coating to Cordis Corp. for distribution.
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510(k) clearances by this applicant
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|---|---|---|
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| SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON (K103095) | Medtronic, Ireland | 2010-10-22 |
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