VIGOR(TM) DR PACEMAKER SYSTEM
FDA premarket approval P940031/S007 · decided 1997-01-14
Approval details
- PMA number
- P940031
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIGOR(TM) DR PACEMAKER SYSTEM
- Applicant
- Boston Scientific
- Date received
- 1996-11-20
- Decision date
- 1997-01-14
- Days to decision
- 55 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085. THIS SUPPLEMENT QUALIFIED FOR REVIEW UNDER THE PMA SUPPLEMENT PILOT DESCRIBED IN THE MARCH 20, 1996 "DEAR PRESIDENT OR CEO" LETTER REGARDING CHANGES IN MANUFACTURING SITES.
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