ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM
FDA premarket approval P980037/S012 · decided 2005-02-04
Approval details
- PMA number
- P980037
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Boston Scientific Corp
- Date received
- 2005-01-07
- Decision date
- 2005-02-04
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- CHANGE FOR THE SUPPLY LINE NUT OF THE ANGIOJET PUMP SET.
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