PMA P980035S837
- Device
- Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDRS1, SED01, SEDR01, SES01, VEDR01); Adapta, Versa, Sensia IPG (SEDRL1); Ad
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S837
- Product code
- NVZ
- Decision date
- 2026-03-27
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- reduced frequency of Laser Ribbon Bonding process monitoring
Current openFDA PMA Record#
- Device
- Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDRS1, SED01, SEDR01, SES01, VEDR01); Adapta, Versa, Sensia IPG (SEDRL1); Ad
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S837
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2026-03-27
- Decision code
- OK30
- Date received
- 2026-03-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reduced frequency of Laser Ribbon Bonding process monitoring