ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM
FDA premarket approval P900056/S025 · decided 1999-02-09
Approval details
- PMA number
- P900056
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 1998-08-14
- Decision date
- 1999-02-09
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the validation protocol for the extended three year shelf life for the BSC Northwest guide wires.
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|---|---|---|
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