MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520
FDA premarket approval P960014 · decided 1998-10-05
Approval details
- PMA number
- P960014
- Trade name
- MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Global Therapeutics, Inc.
- Date received
- 1996-05-10
- Decision date
- 1998-10-05
- Days to decision
- 878 days
- Decision code
- APWD
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Broomfield, CO
- Statement
- Indicated for balloon dilatation of the stenotic portion of a coronary or bypass graft stenosis for the purpose of improving myocardial perfusion.
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