PMA P880027S053

Device: BONNIE SLIDING RAIL PTCA CATHETERS
Applicant: Boston Scientific
PMA number: P880027
Supplement: S053
Product code: LOX
Decision date: 1997-11-21
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for a 3 and 1/2 year shelf life for the Bonnie(TM) Slidng Rail Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.

Current openFDA PMA Record

Device: BONNIE SLIDING RAIL PTCA CATHETERS
Applicant: Boston Scientific
PMA number: P880027
Supplement: S053
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1997-11-21
Decision code: APPR
Date received: 1997-10-24
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a 3 and 1/2 year shelf life for the Bonnie(TM) Slidng Rail Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.