ROTABLATOR(R) ROTALINK EXCHANGEABLE CATHETER
FDA premarket approval P900056/S059 · decided 2000-12-29
Approval details
- PMA number
- P900056
- Supplement
- S059
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ROTABLATOR(R) ROTALINK EXCHANGEABLE CATHETER
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2000-12-06
- Decision date
- 2000-12-29
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- CHANGE TO THE MANUFACTURING PROCESS FOR THE ROTABLATOR ROTALINK ADVANCER. THE CHANGE WILL INCREASE THE PRESSURE WITH WHICH THE FRONT PLUG IS PRESSED INTO THE TURBINE HOUSING.
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