BOSTON SCINTIFIC SCIMED PTCA CATHETER
FDA premarket approval P880027/S060 · decided 2001-07-30
Approval details
- PMA number
- P880027
- Supplement
- S060
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BOSTON SCINTIFIC SCIMED PTCA CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 2001-07-12
- Decision date
- 2001-07-30
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR A MODIFICATION TO THE WARNING STATEMENT IN THE DIRECTIONS FOR USE MANUAL TO EXPAND ON THE POTENTIAL AFFECT OF RE-PROCESSING OR RE-STERILIZATION.
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