ROTAWIRE GUIDE WIRE, A COMPONENT OF THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
FDA premarket approval P900056/S083 · decided 2005-09-27
Approval details
- PMA number
- P900056
- Supplement
- S083
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ROTAWIRE GUIDE WIRE, A COMPONENT OF THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2005-04-11
- Decision date
- 2005-09-27
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC. (FORMERLY COSMED STERILIZATION GROUP OF NEW JERSEY), SOUTH PLAINFIELD, NEW JERSEY.
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