PMA P880065S004
- Device
- MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P880065
- Supplement
- S004
- Product code
- LOT
- Decision date
- 1999-04-21
- Generic name
- PULSE-GENERATOR, PROGRAM MODULE
- Approval order statement
- Approval for a manufacturing site located at SCIMED Life Systems, Inc., Two SCIMED Place, Maple Grove, MN 55311.
Current openFDA PMA Record#
- Device
- MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
- Applicant
- Boston Scientific Corp
- PMA number
- P880065
- Supplement
- S004
- Product code
- LOT
- Generic name
- PULSE-GENERATOR, PROGRAM MODULE
- Decision date
- 1999-04-21
- Decision code
- APPR
- Date received
- 1998-02-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at SCIMED Life Systems, Inc., Two SCIMED Place, Maple Grove, MN 55311.