GOLDIE TM AND GOLDIE TM LONGY PTCA CATHETERS
FDA premarket approval P880027/S044 · decided 1997-02-19
Approval details
- PMA number
- P880027
- Supplement
- S044
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GOLDIE TM AND GOLDIE TM LONGY PTCA CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 1997-01-07
- Decision date
- 1997-02-19
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- INCREASE IN RATED BURST PRESSURE FOR THE GOLDIE(TM) AND GOLDIE(TM) LONGY PTCA CATHETERS.
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