PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)
FDA premarket approval P880027/S058 · decided 2001-03-27
Approval details
- PMA number
- P880027
- Supplement
- S058
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 2001-02-27
- Decision date
- 2001-03-27
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- CHANGE FROM AN INTERNAL PARTICULATE MAXIMUM LEVEL TO AN INTERNAL PARTICULATE ACTION LEVEL OF 75,000 PARTICLES >=10 MICRONS FOR THE FINISHED PRODUCT.
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