PMA P950020S011
- Device
- CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S011
- Product code
- LIT
- Decision date
- 2005-03-08
- Classification
- Catheter, Angioplasty, Peripheral, Transluminal
- Generic name
- Catheter, angioplasty, peripheral, transluminal
- Approval order statement
- APPROVAL FOR AN ALTERNATE IN-HOUSE STERILIZATION SITE LOCATED IN QUINCY, MASSACHUSETTS.
Current openFDA PMA Record#
- Device
- CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S011
- Product code
- LIT
- Generic name
- Catheter, angioplasty, peripheral, transluminal
- Decision date
- 2005-03-08
- Decision code
- APPR
- Date received
- 2004-10-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE IN-HOUSE STERILIZATION SITE LOCATED IN QUINCY, MASSACHUSETTS.