BOSTON SCIENTIFIC SCIMED PTCA CATHETERS
FDA premarket approval P880027/S057 · decided 2000-04-26
Approval details
- PMA number
- P880027
- Supplement
- S057
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- BOSTON SCIENTIFIC SCIMED PTCA CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 2000-03-22
- Decision date
- 2000-04-26
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for a manufacturing site located at Boston Scientific Ireland Ltd., Galway, Ireland and for a sterilization site located at Isotron Ireland Ltd, County Offaly, Ireland.
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