ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
FDA premarket approval P900056/S029 · decided 1999-10-15
Approval details
- PMA number
- P900056
- Supplement
- S029
- Supplement type
- Special (Immediate Track)
- 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
- 1999-09-17
- Decision date
- 1999-10-15
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for labeling changes to the Instructions for Use for the Rotablator System.
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