MICROSOFTRAC TM (PTCA) CATHETER
FDA premarket approval P880027/S005 · decided 1990-08-10
Approval details
- PMA number
- P880027
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MICROSOFTRAC TM (PTCA) CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 1989-12-21
- Decision date
- 1990-08-10
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
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