ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM
FDA premarket approval P900056/S024 · decided 1998-09-02
Approval details
- PMA number
- P900056
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 1998-08-11
- Decision date
- 1998-09-02
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval to provide the Rotablator(R) RotaLink system to the user in a pre-connected configuration. The device, as modified, will be marketed under the trade name Rotoblator(R) RotaLink Plus(TM) Rotational Angioplasty system and is indicated as a means of providng percutaneous rotational coronary angioplasty, as a sole therapy or with adjunctive balloon angioplasty, in patients with coronary artery disease who are candidates for coronary artery bypass graft surgery and who meet one of the follow
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