CHUBBY(TM) PTCA CATHETERS
FDA premarket approval P880027/S040 · decided 1996-09-04
Approval details
- PMA number
- P880027
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CHUBBY(TM) PTCA CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 1996-03-25
- Decision date
- 1996-09-04
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE CHUBBY SLIDING RAIL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
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