PMA P900023S035
- Device
- BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S035
- Product code
- DSQ
- Decision date
- 2001-03-15
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT ABIOMED, INC., DANVERS, MASSACHUSETTS.
Current openFDA PMA Record#
- Device
- BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM
- Applicant
- Abiomed Cardiovascular, Inc.
- PMA number
- P900023
- Supplement
- S035
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2001-03-15
- Decision code
- APPR
- Date received
- 2001-02-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT ABIOMED, INC., DANVERS, MASSACHUSETTS.