CUTTING BALLOON ULTRA 2
FDA premarket approval P950020/S008 · decided 2003-06-04
Approval details
- PMA number
- P950020
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CUTTING BALLOON ULTRA 2
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific Corp
- Date received
- 2003-03-21
- Decision date
- 2003-06-04
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR A TWO YEAR SHELF LIFE FOR BOTH THE OVER-THE-WIRE (OTW) AND MONORAIL (MR) DEVICES.
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