ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
FDA premarket approval P900056/S084 · decided 2005-05-25
Approval details
- PMA number
- P900056
- Supplement
- S084
- Supplement type
- Special (Immediate Track)
- Trade name
- ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2005-04-25
- Decision date
- 2005-05-25
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR AN ADDITIONAL QUALITY CONTROL (QC) INSPECTION METHOD USING THE PASSAGE OF GUIDEWIRE THROUGH THE ROTALINK PLUS DEVICE LUMEN TO VERIFY THE DEVICE IS FREE FROM OBSTRUCTIONS.
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