PMA P880027S057
- Device
- Boston Scientific Scimed Ptca Catheters
- Applicant
- BOSTON SCIENTIFIC
- PMA number
- P880027
- Supplement
- S057
- Decision date
- 2000-04-26
Current openFDA PMA Record
- Device
- BOSTON SCIENTIFIC SCIMED PTCA CATHETERS
- Applicant
- Boston Scientific
- PMA number
- P880027
- Supplement
- S057
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2000-04-26
- Decision code
- APPR
- Date received
- 2000-03-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order 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.