PMA P880065S003
- Device
- Mansfield Sci. Aortic Valvuloplasty Catheter
- Applicant
- Boston Scientific Corp.
- PMA number
- P880065
- Supplement
- S003
- Decision date
- 1997-09-08
Current openFDA PMA Record
- Device
- MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P880065
- Supplement
- S003
- Product code
- LOT
- Generic name
- PULSE-GENERATOR, PROGRAM MODULE
- Decision date
- 1997-09-08
- Decision code
- APPR
- Date received
- 1997-03-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for: 1) an alternate manufacturing and sterilization facility; 2) use of the Oxyfume 2000 sterilant gas mixture for sterilization; 3) use of a parametric release instead of the biological indicators product release process; and 4) use of a revised labeling format, which replaces the Mansfield name with the SCIMED(R) name.