PAS LACROSSE TM PTCA CATHETER
FDA premarket approval P930012/S001 · decided 1996-04-02
Approval details
- PMA number
- P930012
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PAS LACROSSE TM PTCA CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Progressive Angioplasty Systems, Inc.
- Date received
- 1995-10-04
- Decision date
- 1996-04-02
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- APPROVAL FOR THE USE OF 100% ETHYLENE OXIDE STERILIZATION TO BE PERFORMED AT MEDICAL MANUFACTURING CORPORATION, ERIE, PA
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