THE WRAP(PTCA) CATHETER
FDA premarket approval P930012/S006 · decided 1997-05-29
Approval details
- PMA number
- P930012
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE WRAP(PTCA) CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Progressive Angioplasty Systems, Inc.
- Date received
- 1997-03-06
- Decision date
- 1997-05-29
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- APPROVAL FOR THE WRAP(TM) PTCA CATHETER.
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