SCHNEIDER PTCA CATHETERS
FDA premarket approval P880027/S061 · decided 2001-09-07
Approval details
- PMA number
- P880027
- Supplement
- S061
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- SCHNEIDER PTCA CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 2001-08-06
- Decision date
- 2001-09-07
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE ALTERNATE FACILITIES FOR PACKAGING AND LABELING LOCATED AT BOSTON SCIENTIFIC CORPORATION, QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, BEEK, THE NETHERLANDS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.