PMA P880065S002
- Device
- Mansfield Sci. Aortic Valvuloplasty Catheter
- Applicant
- Boston Scientific Corp.
- PMA number
- P880065
- Supplement
- S002
- Decision date
- 1995-10-23
Current openFDA PMA Record
- Device
- MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P880065
- Supplement
- S002
- Product code
- LOT
- Generic name
- PULSE-GENERATOR, PROGRAM MODULE
- Decision date
- 1995-10-23
- Decision code
- APPR
- Date received
- 1995-03-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW CONTRACT STERILIZER AND A CHANGE IN THE STERILIZATION PROCEDURE