PMA P830026S077
- Device
- IMPLANTABLE PACEMAKER
- Applicant
- Boston Scientific
- PMA number
- P830026
- Supplement
- S077
- Product code
- LWP
- Decision date
- 1999-12-02
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for the manufacturing and labeling facility located at Guidant Corp., St. Paul, MN 55112-5798.
Current openFDA PMA Record#
- Device
- IMPLANTABLE PACEMAKER
- Applicant
- Boston Scientific
- PMA number
- P830026
- Supplement
- S077
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1999-12-02
- Decision code
- APPR
- Date received
- 1999-10-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- Approval for the manufacturing and labeling facility located at Guidant Corp., St. Paul, MN 55112-5798.