ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES
FDA premarket approval P900056/S062 · decided 2001-04-17
Approval details
- PMA number
- P900056
- Supplement
- S062
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2001-03-30
- Decision date
- 2001-04-17
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR AN ADDITIONAL MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC MIAMI TECHNOLOGY CENTER (BSMTC), MIAMI, FLORIDA.
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