ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
FDA premarket approval P900056/S090 · decided 2007-10-03
Approval details
- PMA number
- P900056
- Supplement
- S090
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2007-06-19
- Decision date
- 2007-10-03
- Days to decision
- 106 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR REVISIONS TO THE DIRECTIONS FOR USE FOR THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM, GUIDEWIRE WITH WIRECLIP TORQUER.
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