ROTABLATOR ROTALINK ADVANCER AND ROTALINK PLUS
FDA premarket approval P900056/S121 · decided 2013-05-23
Approval details
- PMA number
- P900056
- Supplement
- S121
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ROTABLATOR ROTALINK ADVANCER AND ROTALINK PLUS
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2013-02-14
- Decision date
- 2013-05-23
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR USE OF AN ALTERNATE PROCESSING AID IN THE MANUFACTURE OF THE RESIN USED TO MAKE THE INNER PTFE LINER IN THE SLIDE TUBE COMPONENT OF THE ROTALINK ADVANCER.
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