ROTABLATOR(R)
FDA premarket approval P900056/S009 · decided 1995-08-14
Approval details
- PMA number
- P900056
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ROTABLATOR(R)
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 1994-12-08
- Decision date
- 1995-08-14
- Days to decision
- 249 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- 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
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