PMA P900056S009

Device: ROTABLATOR(R)
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S009
Product code: MCX
Decision date: 1995-08-14
Classification: Catheter, Coronary, Atherectomy
Generic name: CATHETER, CORONARY, ATHERECTOMY
Approval order statement: CHANGE IN LOCATION FOR SEAMED CORPORATION, THE MANUFACTURER OF THE CONSOLE USED WITH THE ROTABLATOR SYSTE, FROM 11810 NORTH CREEK PARKWAY NORTH, BOTHELL, WASHINGTON, TO WEST WILLOWS TECHNOLOGY CENTER, N.E. 87TH STREET, REDMOND, WASHINGTON

Current openFDA PMA Record#

Device: ROTABLATOR(R)
Applicant: Boston Scientific Corp
PMA number: P900056
Supplement: S009
Product code: MCX
Generic name: CATHETER, CORONARY, ATHERECTOMY
Decision date: 1995-08-14
Decision code: APPR
Date received: 1994-12-08
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN LOCATION FOR SEAMED CORPORATION, THE MANUFACTURER OF THE CONSOLE USED WITH THE ROTABLATOR SYSTE, FROM 11810 NORTH CREEK PARKWAY NORTH, BOTHELL, WASHINGTON, TO WEST WILLOWS TECHNOLOGY CENTER, N.E. 87TH STREET, REDMOND, WASHINGTON